Clinical Trials
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Dermatology
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Apr 2013The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Apr 2013The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.
Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis
Mar 2013This study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various different sources, including summary of product characteristics (SPCs) and the German S3 guideline on psoriasis care, health care utilization data and official statistics. The study aims to investigate the comparative cost-effectiveness of biologic and conventional systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as well as indirect cost will be considered.
An Open, Non-comparative Study of the Efficacy and Safety of Treatment of Acne Scars With Restylane Vital Lidocaine
Mar 2013The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated
Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis
Feb 2013This is a clinical study evaluating an innovative cell therapy procedure. The objective of this study was to evaluate the effects of injection of autologous stromal vascular fraction of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United Kingdom) in digital in patients with scleroderma cutaneous hands.
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Feb 2013A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 30 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
The NEMO trial (NRAS melanoma and MEK inhibitor): A randomized Phase III, open label, multicenter, two-arm study comparing MEK162 versus dacarbazine in patients with advanced unresectable or metastatic NRAS mutation-positive melanoma
Feb 2013To determine whether treatment with MEK162 prolongs PFS as compared to dacarbazine in patients with advanced unresectable, or metastatic NRAS mutation-positive melanoma who are previously untreated or who have progressed on or after prior first-line immunotherapy for metastatic disease.
A phase IV, postmarketing, open-label, extension (rollover) study of vemurafenib in patients with BRAFV600 mutation−positive malignancies previously enrolled in an antecedent vemurafenib protocol
Feb 2013To provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated for an antecedent vemurafenib protocol without meetings its definite criteria for disease progression there and may potentially benefit from continued treatment with vemurafenib
Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.
Feb 2013The purpose of this study is to determine whether QAW039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (AD).
A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis
Jan 2013A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy of GSK2586184 in patients with chronic plaque psoriasis. There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184 concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will take 400 mg GSK2586184.
Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)
Jan 2013The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.
Emollients in the Management of Atopic Dermatitis
Jan 2013The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184
Jan 2013This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE). This study will also investigate the safety and tolerability of repeat doses of GSK2586184.
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis (TRANSFIGURE)
Jan 2013To demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis (GESTURE)
Jan 2013To demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess long term efficacy, safety and tolerability of secukinumab.
Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.
Jan 2013To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
A Multi-Center, Randomized, Controlled, Two-Arm, Pivotal Phase III Study to Evaluate the Safety and Efficacy of MK-3475 Compared to Ipilimumab in Patients with Advanced Melanoma
Jan 2013To evaluate the overall survival (OS) in patients with advanced MEL receiving either MK-3475 or IPI.
Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
Jan 2013The main objective is to investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.
Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma (AIMM)
Jan 2013The objective of the present trial is: - to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. - to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP - to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP
A prospective, single-centre, feasibility study evaluating the prevalence of diagnostic clinical imaging features of subclinical enthesitis in patients with moderate to severe plaque psoriasis and the response to skin directed treatment with Ustekinumab
Jan 2013Do the imaging features of subclinical enthesopathy (the earliest change seen in psoriatic arthritis), as measured by peripheral joint ultrasound (USS) and whole body MRI, in patients with moderate-to-severe psoriasis (PASI>10), change when treated for 24 weeks with ustekinumab (at standard dose) for their psoriatic skin disease?
Effects of Omega-3 Fatty Acid Supplementation in Acne Patients
Jan 201360 patients receiving isotretinoin and 90 subjects receiving oral antibiotic therapy will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks.
Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma
Jan 2013Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and prior first-line therapy (Ipilimumab-immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
Jan 2013To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals
Jan 2013To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with 1 versus 3 months intervals
Rituximab in Systemic Sclerosis (RECOVER)
Dec 2012The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis
A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment versus Chemotherapy for Subjects with Advanced Melanoma who Progressed after Initially Achieving Disease Control with Ipilimumab Therapy Protocol Amendment 01- Pharmacogenetics Blood Sample Amendment, site specific (version 1.0, dated 27-Aug-2012)
Dec 2012The purpose of the study is to compare the 18-month overall survival rate in subjects with advanced melanoma receiving ipilimumab monotherapy (3 mg/kg) as retreatment versus chemotherapy of investigator’s choice in subjects who are randomized at the time of ipilimumab retreatment eligibility. This comparison will be done after the last randomized subject had the chance to be followed for 18 months.
Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis. (SPECIES)
Dec 2012The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of the hand with Laser speckle contrast imaging discriminate between patients with systemic sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus
Nov 2012To evaluate the efficacy of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE at Day 169 (Week 24).
Adoptive T cell therapy plus vaccination in metastatic melanoma patients
Nov 2012The primary objective of this study is to demonstrate safety of ACT plus low does IFN-alpha followed by vaccination with autologous tumor cells.
A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects with Previously Untreated Unresectable or Metastatic Melanoma Pharmacogenetics Blood Sample Amendment 01- dated 20-sep-12, version 1.0
Nov 2012The purpose of this study is to compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Dacarbazine in subjects with previously untreated, unresectable or metastatic melanoma
Emollients in the management of atopic dermatitis in children: prevention of flares.
Nov 2012To assess the ability of DEXERYL to prevent flares after treatment of a previous flare by a topical corticosteroid.
Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.
Nov 2012The main objective of the trial is to prospectively assess the efficacy, toxicity, quality of life with PEG IFN alfa-2b as compared to observation after adequate surgery for ulcerated primary cutaneous melanomas with T(2-4)bN0M0. The primary objective is to determine whether post-operative adjuvant therapy with PEG IFN alfa-2b improves relapse-free survival (PFS) as compared to observation.
COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resection.
Nov 2012To evaluate the efficacy of dabrafenib and trametinib combination therapy compared to two placebos with respect to relapse-free survival (RFS) in patients with completely resected, histologically confirmed, BRAF V600E/K high-risk, stage III cutaneous melanoma
A multi-centre, randomised, double-blind, placebo-controlled, dose ranging study to evaluate the safety and efficacy of GSK2586184 in patients with chronic plaque psoriasis
Nov 2012To estimate the relationship between dose of GSK2586184 and clinical response as assessed by PASI score after 12 weeks of treatment in patients with moderate to severe plaque-type psoriasis.
A phase III, double-blind, placebo-controlled study of vemurafenib versus vemurafenib plus GDC-0973 in previously untreated BRAFV600-mutation positive patients with unresectable locally advanced or metastatic melanoma
Oct 2012To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by prolongation of progression-free survival (PFS), as assessed by the study site investigator.
An adaptive, placebo-controlled, Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with mild to moderate systemic lupus erythematosus.
Oct 2012• To estimate the relationship between dose of GSK2586184 and pharmacodynamic effect on expression of selected messenger ribonucleic acid (mRNA) transcripts following 2 weeks of treatment in SLE patients • To estimate the relationship between dose of GSK2586184 and clinical response as assessed by SELENA SLEDAI score following 12 weeks of treatment in SLE patients • To evaluate the safety and tolerability of repeat doses of GSK2586184 in SLE patients.
A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Atopic Dermatitis
Oct 2012To compare the effectiveness of three doses of topically applied DGLA cream, versus placebo, in the treatment of adult patients with mild to moderate dermatitis
A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE.
Oct 2012The primary aim of the trial is to assess whether the anticoagulant effects of rivaroxaban are not inferior to those of warfarin. This will be achieved by comparing the percentage change in endogenous thrombin potential (ETP), assessed by the thrombin generation test (TGT), from randomisation to day 42. The TGT is a global measure of anticoagulation, which can assess the anticoagulant effects of both rivaroxaban and warfarin (drugs with very different modes of action on the coagulation mechanism). The TGTs will be performed in the UCL Haemostasis Research Unit.
An exploratory study evaluating the efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis
Sep 2012To investigate the clinical efficacy on itch of treatment with cromoglicate cream in subjects with itchy psoriasis
A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
Sep 2012Exploratory, international, multi-centre, randomized, investigator blinded study in acne
A randomized phase II trial comparing bevacizumab monotherapy with dacarbazine (DTIC) in treatment of malignant melanoma, focusing on angiogenic markers and prevention of hypertension.
Sep 2012The primary objective of this trial is to compare efficacy of bevacizumab monotherapy with standard chemotherapy (DTIC) in patients with metastatic or unresectable malignant melanoma.
Potentiating clinical and immunological effects of chemotherapy by neutralizing acidic pH at tumor site: a phase II randomized study in melanoma patients
Sep 20121. Significant increase in the systemic anti-tumor immune response (evaluated as IFN gamma Elispost in response to autologous melanoma cells or HLA-compatible antigenic peptides and phenotypic profile leukocyte, including of immunosoppressorie subpopulations immunosoppressorie as Treg and MDSC) in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment; 2. Increase of pathological tumor response and of the anti-tumor immune infiltrate T, possibly associated with a decrease of negative regulatory cells (Treg and MDSC) in ECT treated lesions, in the arms of combination ECT IL2 and ECT LANS, compared to ECT as a single treatment
A multi-center, randomized, double-blind, three-arm, 16 week, adaptive phase III clinical study to investigate the efficacy and safety of LAS41008 vs LASW1835 and vs Placebo in patients with moderate to severe plaque psoriasis
Aug 2012The primary objectives of the study are: - Superiority of LAS41008 versus placebo based on the proportion of subjects achieving PASI 75 at week 16 (a 75% reduction in the Psoriasis Area and Severity Index, PASI, compared to baseline. - Superiority of LAS41008 versus placebo based on the proportion of subjects achieving a score of “clear” or ”almost clear” in the Physician’s Global Assessment (PGA) after 16 weeks of treatment. - Non-inferiority of LAS41008 compared to LASW1835 (internal code for Fumaderm®) regarding PASI 75 after 16 weeks of treatment.
A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
Aug 2012Primary Placebo-family Objectives Compared with placebo: • To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at week 12 • To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving success (clear [0] or almost clear [1]) on the static physician’s global assessment (sPGA) at week 12
A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa (HiTS)
Aug 2012The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.
A phase II study of intratumoral application of L19IL2/L19TNF in melanoma patients in clinical stage III or stage IV M1a with presence of injectable cutaneous and/or subcutaneous lesions.
Jul 2012Efficacy of L19IL2/L19TNF-treated lesions measured as : Rate of patients with complete response (CR) of L19IL2/L19TNF-treated lesions at week 12 (day 85).
A 12-Week Multicenter, Randomized, Double-Blind, Placebo Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate to Severe Plaque Psoriasis with a Long-Term Extension Period
Jul 2012Efficacy of ixekizumab vs. etanercept and placebo in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at week 12
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Jul 2012The primary objective is to evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.
Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
Jul 2012To determine the tumor antigen-specific immune response induced by the treatment and to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy
Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
Jul 2012To determine the tumor antigen-specific immune response induced by the treatment 2. to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy
A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
Jul 2012Primary Placebo-family Objectives Compared with placebo: • To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at week 12 • To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving success (clear [0] or almost clear [1]) on the static physician’s global assessment (sPGA) at week 12
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus
Jun 2012To evaluate the efficacy of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE at Day 169 (Week 24).
Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis
Jun 2012To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.
Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis
Jun 2012To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.
Prospective feasibility study for the evaluation of indocyanine green and near-infrared imaging in sentinel lymph node biopsy for cutaneous melanoma patients: The "RED-GREEN-BLUE" melanoma study.
Jun 2012The principal research question is to assess the sensitivity of indocyanine green (ICG) for Sentinel lymph node detection in cutaneous melanoma in combination with technetium radioisotope and patent blue dye.
A multicenter, double-blind, randomized withdrawal extension study of subcutaneous secukinumab in prefilled syringes to demonstrate long-term efficacy, safety and tolerability up to 2 years in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab
Jun 2012To demonstrate the efficacy of secukinumab 150 mg or 300 mg in subjects with moderate to severe chronic plaque-type psoriasis, who were PASI 75 responders at Week 52 of the core study, with respect to loss of PASI 75 up to Week 68, compared to placebo.
Adjuvant PEG Intron in Ulcerated Melanoma
May 2012The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.
Safety and efficacy of intramuscular electrotransfer of plasmid AMEP in patients suffering from advanced or metastatic melanoma: an open-label phase I/II clinical trial the AIMM Study (AMEP in metastatic melanoma)
May 2012Part 1: Phase I Patients with advanced or metastatic melanoma will receive intramuscularly increasing doses of plasmid AMEP Primary objective: - To determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. Part 2: Extension Phase I/II Patients with advanced or metastatic melanoma will receive intramuscularly the recommended dose of plasmid AMEP either alone or in combination with dacarbazine Primary objective: - To confirm the safety and tolerability of intramuscular electrotransferred Plasmid AMEP at the established recommended dose, alone or in combination.
A Study of RO5185426 in Patients With Metastatic Melanoma
May 2012This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up of 24 months after discontinuation of the study drug.
A randomized, double-blind, placebo controlled, multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate efficacy after twelve weeks of treatment, and to assess the safety, tolerability, usability and long-term efficacy in subjects with chronic plaque-type psoriasis
May 2012To demonstrate the efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
A randomized, double-blind, parallel-group, placebo-controlled study to assess the safety of REGN668 administered concomitantly with topical corticosteroids to patients with moderate-to-severe Atopic dermatitis
Apr 2012The primary objective of the study is to assess the safety of repeated subcutaneous (SC) doses of REGN668 administered concomitantly with topical corticosteroids (TCS) in adult patients with moderate-to-severe atopic dermatitis (AD).
A phase III, randomised, open-label study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to the BRAF inhibitor vemurafenib in subjects with unresectable (stage IIIc) or metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma
Apr 2012To establish the superiority of dabrafenib and trametinib combination therapy with vemurafenib monotherapy with respect to overall survival (OS) for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.
MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients
Apr 2012The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients.
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE)
Apr 2012• To evaluate the efficacy of belimumab administered SC in adult subjects with SLE. • To evaluate the safety and tolerability of belimumab administered SC in adult subjects with SLE.
A Clinical Trial Evaluating the Safety and Efficacy of the KLOX Biophotonic System in Moderate to Severe Acne
Apr 2012The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic System in patients with moderate to severe facial acne vulgaris using a split-face design (treated hemiface vs untreated hemiface).
A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE)
Apr 2012• Evaluate the safety and tolerability of belimumab in the pediatric SLE population • Evaluate the pharmacokinetics of belimumab in the pediatric SLE population. • Evaluate the efficacy of belimumab in the pediatric SLE population • Evaluate the effects of belimumab on the quality of life in the pediatric SLE population.
Study to evaluate the efficacy and safety of Anakinra in the treatment of articular manifestations refractory to conventional therapy in Systemic Lupus Erythematosus patients
Apr 2012The primary objective of this study is to evaluate the efficacy of Anakinra in patients with SLE and articular manifestations refractory to conventional treatment.
A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic Dermatitis
Apr 2012The primary objective is to establish the therapeutic equivalence between tacrolimus ointment 0.1%, manufactured by Intas Pharmaceuticals Ltd., India and Protopic® (tacrolimus), 0.1% topical ointment manufactured by Astellas Pharma B.V., The Netherlands and marketed by Astellas Pharma Europe Ltd. and to show superiority over vehicle in the treatment of moderate to severe Atopic Dermatitis in adult population.
A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma
Apr 2012To establish the superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)
Apr 2012The primary objective of this study is to evaluate the safety and tolerability of LY2127399 (120 mg every 4 weeks [Q4W] + SoC or 120 mg every 2 weeks [Q2W] + SoC) in patients with SLE who have completed 52 weeks of treatment in either Study BCDS or Study BCDT. Safety and tolerability assessments for Study BCDX include the following: - Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) - Laboratory evaluations (including chemistry, immunoglobulins, hematology, B cell counts, and urinalysis) - Immunogenicity (anti-LY2127399 antibodies)
Multicenter phase 1/2a study using T-cell receptor gene therapy in metastatic melanoma
Apr 2012To study the efficacy of this treatment strategy in inducing tumor-specific T cell immunity as measured by the presence of Mart-1 specific T cells in peripheral blood samples on several time points following adoptive transfer.
A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Metastatic Melanoma Revised Protocol 02 incorporating Protocol Amendments 05 and 09 + Pharmacogenetics Blood Sample Amendment- Site Specific (version 1.0 dated 10-Nov-11) + Protocol Amendment 03- Site Specific (version 1.0 dated 09-nov-2011) + Protocol Amendment 07- Site Specific (version 1.0 dated 21-mar-2012) + Biomarker Sub-Study Protocol amendment 06 version 1.0, dated 29-May-2012- Site-specific
Mar 2012The purpose of this study is to determine whether giving ipilimumab at a dose of 10 mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving ipilimumab at a dose of 3 mg/kg
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis
Mar 2012Efficacy of ixekizumab vs. etanercept in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks.
Adult Vettel Pilot Clinical Study
Feb 2012This is a non comparative pre-CE marking pilot clinical investigation is required to evaluate the safety and performance in intended use of the Verruca treatment - NPD396, Class IIa medical device for verrucas in the adult population. The treatment regime will be topical application of the Verruca treatment to the verruca, identified as the reference, once daily for 4 weeks. Patient & investigator derived outcomes will also be collected to assess clinical performance and adverse events and adverse device effects will be reported to assess safety profile. Patient assessments will take place pre-treatment to determine patient demography, baseline clinical status, pain and verruca size prior to treatment. Compliance with treatment schedule will be collected via patient diary cards. Furthermore, patients will be assessed on day 2 after starting treatment and then again at 7, 14, 21 & 28 days after starting treatment. Diary cards will completed through-out the investigation.
Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II)
Jan 2012Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks, measured by laser Doppler imaging, in SSc subjects with an early or active SSc pattern, measured with nailfold capillaroscopy (NFM), with ongoing digital ulcer disease and a history of DU disease in the past 2 years.
Melanoma Margins Excision Trial
Jan 2012Recent data analysis has shown that data are seriously lacking on the safety and efficacy of margins less than 2cm for melanomas >2mm in Breslow thickness, and arguably insufficient for melanomas >1mm in thickness, for loco-regional control of melanoma recurrence. No RCT currently addresses 1 vs 2cm margins for melanomas in the >1mm thickness group. A trial is needed to answer this question.
Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
Jan 2012The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma
Jan 2012This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration.
Protocol I1F-MC-RHAZ A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients with Moderate-to-Severe Plaque Psoriasis
Dec 2011Efficacy of ixekizumab in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks
A randomized, double-blind, placebo-controlled, repeat-dose study of the efficacy, safety, tolerability, and pharmacodynamics of subcutaneously-administered REGN668 in adult patients with extrinsic moderate-to-severe atopic dermatitis
Dec 2011The primary objective is to assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668 in adult patients with moderate-to-severe atopic dermatitis (AD).
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
Dec 2011The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.
Characterization of the Melanoma-Specific Immune Response
Dec 2011The aim of this study is to study T-cells. Blood will be collected and the samples will be used to generate T cell clones. Two separate blood draws will be required at the maximum.
Neurotropic Melanoma of the Head and Neck
Dec 2011This is a 2-armed randomised controlled trial comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Uncontrolled studies suggest that this form of primary melanoma has a high risk of local recurrence and that postoperative radiation therapy may substantially reduce that risk. Patients who are eligible on the basis of the pathology of the excised melanoma will be offered the opportunity to take part in the trial. Those randomised to receive radiation therapy will be treated with a simple technique encompassing the surgical bed plus a margin. Radiation will commence within 3 months of surgery
Optimising outpatient care in mild to moderate psoriasis by a newly developed ‘Topical Treatment Optimising Programme’ - an international study using Daivobet®/Dovobet® Gel (‘PSO-TOP’)
Dec 2011To assess the value of the ‘Topical Treatment Optimising Programme’ in the topical treatment of insufficiently treated mild to moderate psoriasis after 8 weeks of once daily treatment with Daivobet® Gel.
A randomised phase 2 study of paclitaxel with or without GSK1120212 in advanced wt BRAF melanoma
Nov 2011Phase 1 - To establish the maximum tolerated dose of GSK1120212 in combination with paclitaxel in the treatment of patients with advanced melanoma. Phase 2 - To compare the efficacy of GSK1120212 in combination with paclitaxel, compared with paclitaxel alone in the treatment of patients with advanced or metastatic melanoma.
An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod)
Sep 2011To study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757
A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
Aug 2011The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Aug 2011There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and
Interferon Responses in Eczema Herpeticum (ADEH) (IFN)
Jul 2011Atopic dermatitis (AD) is a chronic skin disorder characterized by recurrent viral skin infections. A small subset of patients with AD suffer from disseminated viral infections, e.g., eczema herpeticum (ADEH+), after herpes simplex infection (HSV) or eczema vaccinatum (EV) after smallpox vaccination. Interferon (IFN)-γ plays a critical role in the innate and acquired immune responses by activating macrophages, enhancing natural killer cell activation, and promoting T cell differentiation, as well as regulating B cell isotype switching to immunoglobulin (Ig) G2a. Recent studies have demonstrated that IFN-γ generation was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is to determine if deficient IFN-γ induction leads to susceptibility to HSV infection in ADEH+ patients.
Comparison of Moisturisers for the Prevention of Atopic Dermatitis Relapse– a Randomised, Double Blind Controlled Study (COMPADRE)
Jun 2011The primary objective is to show that a barrier strengthening moisturiser is superior to a base cream in preventing eczema relapse in patients with AD.
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus
May 2011The primary objective of this study is to evaluate the efficacy of sifalimumab compared to placebo in subjects with chronic, moderately-to-severely active SLE.
Exploratory study to assess facial tolerability after daily application of several concentrations and formulations containing CD5789 in acne subjects
Apr 2011To evaluate the facial tolerability and subject’s adherence to treatment of different formulations of CD 5789 when applied QD over 4 weeks by acne subjects, in comparison with Tazarotene 0.1%.
The effect of GLP-1 in psoriasis
Apr 2011The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial.
A randomized, double-blind, double-dummy, placebo controlled, multicenter study of subcutaneous secukinumab to demonstrate efficacy after twelve weeks of treatment, compared to placebo and etanercept, and to assess the safety, tolerability and long-term efficacy up to one year in subjects with moderate to severe chronic plaque-type psoriasis.
Apr 2011Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis over 12 weeks based on PASI and IGA
Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis
Apr 2011Evaluate the safety of 6.0 mg/kg and 12 mg/kg SM101 per week in SLE patients with or without a history of lupus nephritis.
The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
Apr 2011To determine if anti-IgE can improve very severe eczema in children, who have not responded to the usual 1st and 2nd line treatments for eczema (assessed by the eczema severity score, SCORAD), as compared to a placebo.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1)
Feb 2011The primary objective of this study is to evaluate the efficacy of LY2127399 120 mg Q4W + SoC or 120 mg Q2W + SoC compared to placebo + SoC as assessed by the proportion of patients who achieve a response as defined by the SRI-5 at Week 52 in patients with SLE. Response is defined as follows: - Reduction of ≥5 points from baseline in SELENA-SLEDAI score; - No new BILAG A or no more than 1 new BILAG B disease activity scores; and - No worsening (defined as an increase of ≥0.3 points from baseline) in PGA.
A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4)
Feb 2011The primary objective of the study is to assess the safety and tolerability of long-term epratuzumab treatment in subjects with SLE.
A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1)
Feb 2011The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and immunosuppressants) continued from Baseline.
Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis
Jan 2011To demonstrate the effect of macitentan on the reduction of the cumulative number of new digital ulcers at Week 16 in patients with systemic sclerosis and ongoing digital ulcer (DU) disease.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2)
Jan 2011The primary objective of this study is to evaluate the efficacy of LY2127399 120 mg Q4W + SoC or 120 mg Q2W + SoC compared to placebo + SoC as assessed by the proportion of patients who achieve a response as defined by the SRI-5 at Week 52 in patients with SLE. Response is defined as follows: - Reduction of ≥5 points from baseline in SELENA-SLEDAI score; - No new BILAG A or no more than 1 new BILAG B disease activity scores; and - No worsening (defined as an increase of ≥0.3 points from baseline) in PGA.
Proof of concept study of combined allergen immunotherapy and antibiotics for the treatment of chronic atopic eczema
Oct 2010To test whether combined antibiotics and allergen-immunotherapy (desensitisation to the allergen house dust mite) lead to clinical improvement in adults with severe atopic eczema.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety and tolerability of two doses of ACT-128800, an oral S1P1 receptor agonist, administered up to twenty-eight weeks in patients with moderate to severe chronic plaque psoriasis
Aug 2010To demonstrate at Week 16 (the end of the induction period) the efficacy of at least one of two doses of ACT 128800 compared to placebo in patients with moderate to severe chronic plaque psoriasis based on the proportion of patients with at least 75% improvement of Psoriasis Area and Severity Index (PASI) from baseline to Week 16.
Evaluate Reversal of Pathological Epidermal Phenotype in Severe Atopic Dermatitis (AD) With Suppression of Immune Activation During Cyclosporine A Therapy
Jun 2010Atopic Dermatitis (AD) or eczema is a chronic relapsing inflammatory disease that affects 1-3% of the adults and up to 25% of the children in the United States. Patients with severe AD will be studied during a 24-week study with systemic cyclosporine (Neoral, capsule form) to evaluate the immune suppression and pathological correlation of cyclosporine A in these patients in order to determine the extent to which immune activation drives the pathological epidermal phenotype.
A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis
May 2010To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis in children.
A multicenter extension trial of subcutaneously administered AIN457 in patients with moderate to severe chronic plaque-type psoriasis
Apr 2010To evaluate the long-term safety and tolerability of subcutaneously administered AIN457 in the treatment of moderate to severe chronic plaque-type psoriasis.
A phase 2a proof of concept study comparing three doses of an oral solution of LEO 22811 with a placebo oral solution for the treatment of psoriasis vulgaris
Mar 2010To compare the clinical efficacy of three different doses (0.5 mg, 1.5 mg and 3.0 mg) of an oral solution of LEO 22811 with a placebo oral solution all administered once daily for up to 12 weeks in subjects with psoriasis vulgaris.
Enumeration and Functional Evaluation of Regulatory T-cells in Psoriasis Patients Before and After Treatment with: Calcipotriol/Betamethasone, Acitretin, Narrow-Band UVB and Anti-TNF α Therapy (Etanercept, Adalimumab and Infliximab)
Mar 2010This research will be conducted on Dermatology patients diagnosed with "psoriasis" which is a common skin problem adversly affects the quality of life of affected patients.
Safety and Efficacy of Calcipotriol plus Betamethasone Dipropionate Gel in Adolescent Patients (Aged 12 to 17 Years) with Scalp Psoriasis
Feb 2010The primary objective is to evaluate the safety of once daily use of calcipotriol (50 mcg/g) plus betamethasone (0.5 mg/g) (as dipropionate) gel in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.
A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNα-Kinoid in adult patients with Systemic Lupus Erythematosus.
Feb 2010The primary objective of this trial is to assess the safety and tolerability of three administrations of IFN-K adjuvanted with ISA-51 at four doses (30, 60, 120 or 240 mcg), given on SD0, SD7 and SD28 (+/- a fourth dose on SD84 [Month 3]) in adult subjects with SLE.
Comparison of Five Treatments in Patients With Plantar Warts (VRAIE)
Nov 2009The principal objective of the study is to compare 5 usual strategies in the management of plantar warts which did not cure after 5 weeks of a salicylate ointment given just prior the trial. The trial will include immunocompetent patients coming from the community and should help the office-based dermatologists in the decision-making therapeutic process.
A Phase I Study of Intravenous Recombinant Human IL-15 in Adults With Refractory Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer
Nov 2009•To determine whether rhIL-15 is safe and effective in the treatment of metastatic malignant melanoma or metastatic renal cell carcinoma •To examine how the body processes rhIL-15 after each infusion and determine how it acts on the treated cancer.
Monochloroacetic acid versus cryotherapy in the treatment of warts: A Randomised Clinical Trial (WARTS-2)
May 2009Is treatment with monochloroacetic acid more effective than treatment with cryotherapy regarding patients with handwarts? Is treatment with monochloroacetic acid more effective than combination therapy (treatment with first salicylic acid followed by cryotherapy) regarding patients with plantar warts?
A multicenter, randomized, intra-individual, double blind, vehicle-controlled study to evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks in the treatment of target lesions in adults subjects with atopic dermatitis
May 2009To evaluate the efficacy and safety of CD2027 ointment 9µg/g applied twice daily over 4 weeks versus its vehicle on target lesions in adult subjects with Atopic dermatitis.
A double blind, randomized, placebo controlled, multicenter, dose finding study of oral AEB071 assessing Psoriasis Area and Severity Index (PASI) response as a function of dose and treatment duration (primary outcome) in patients with plaque psoriasis
Apr 2009Efficacy (as assessed by PASI response) of AEB071 in patients with moderate to severe plaque psoriasis as a function of treatment dose and treatment duration.
Efficacy and Safety comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris.
Mar 2009The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.
Exploratory Study to Evaluate the Efficacy and Safety of CD5789 in Subjects with Acne
Mar 2009The objective of this study is to evaluate the efficacy on acne lesions and the safety of CD5789 0.01% and 0.005% after four weeks of once daily application compared to its gel vehicle using clinical and photographic evaluations.
A multi-centre, double-blind, placebo-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm, a topically applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children.
Jan 2009To evaluate the efficacy and safety of topically applied Altoderm in the treatment of atopic dermatitis in children.
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study
Aug 2008To evaluate, in children presenting with atopic dermatitis, the impact of a daily treatment by the emollient V0034CR 01B on the disease symptoms: evolution of the POEM (Patient-Oriented Eczema Measure) score.
bLAC - A phase II double-blind, placebo controlled, clinical proof of concept trial of the efficacy of 8 weeks treatment of cutaneous warts with bLAC in immune suppressed, kidney transplanted patients
Jul 2008The clinical proof of concept of bLAC is to demonstrate a reduction in the area of the wart lesions located on fingers and/or palms and/or toes and/or soles of the feet, (measured by an objective method by drawings of the individual lesions) at two dose levels of bLAC, compared with placebo The lowest dose of bLAC that will be efficacious in treatment of warts will be recommended for further studies.
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Jan 2008This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.
Phase IIa, randomized, double-blind, placebo-controlled, intra-individual left-right limb comparison trial in 25 patients with moderate atopic dermatitis to investigate the efficacy, local irritation, safety, tolerability and pharmacokinetics of twice daily topical applications with 10% ImCOOH cream for 14 days with an additional morning application on Day 15.
Nov 2007Main objectives of the trial are to determine the efficacy of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis; and to determine the safety and tolerability of topical applications of ImCOOH cream administered for 14 days with an additional morning application on Day 15 in patients with atopic dermatitis.
A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.
Sep 2007The primary objective of the study is to show therapeutic efficacy of Zarzenda® cream versus Elidel® 1% cream in children and adolescents with mild to moderate atopic dermatitis.
Double-Blind, Randomised, Active And Placebo Controlled Study To Assess The Clinical Efficacy, Skin Tolerability And Pharmacological Activity Of A New Topical Compound (Ur-1505 0.5%, 1% And 2%) In Patients With Mild To Moderate Atopic Dermatitis
Jun 2007To explore the clinical efficacy of UR-1505 (0,5%, 1% and 2%) applied once daily during 4 weeks, compared with a vehicle without active ingredients and with an active treatment, in adult patients with mild to moderate atopic dermatitis.
Risk of Asthma in Infants With Atopic Dermatitis
Apr 2007Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this study is to determine whether we can identify infants who will develop asthma.
LEO19123 Cream in the Treatment of Atopic Dermatitis A Phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of atopic dermatitis
Jan 2007To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks.
A study to evaluate the role of tacrolimus ointment (Protopic®) 0.1% in the treatment of chronic otitis externa.
Dec 2006To establish the effectiveness of Tacrolimus ointment as a treatment for chronic eczematous otitis externa. This will be evaluated by treatment group comparisons of the patient diary cards, the ENT Specialist’s evaluation and overall assessment.
A two months study of the utility of Elidel cream 1% (pimecrolimus) in the long term management of atopic hand eczema.
Aug 2006To investigate if an Pimecrolimus (pimecrolimus) based treatment regime prolongs the time to relapse after control of a flare compared with a treatment with Pimecrolimus vehicle plus emollients in patients with chronically relapsing atopic hand eczema.
Mechanism of Action of High-Dose IL-2 (Aldesleukin) in Metastatic Melanoma and Kidney Cancer
Mar 2006To better understand how IL-2 causes tumors to shrink.
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