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Clinical trial

Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

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Last updated:1st May 2006
Identifier: NCT00168064

This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)
Enrollment: 260
Study Start Date: May 2006
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure

Arms:
- Active Comparator:
1 (PG - NM (MCH) 0.02%)
- Active Comparator: 2 (AP - MCH(NM) 0.02%)

Category Value
Date last updated at source 2012-10-02
Study type(s) Interventional
Expected enrolment 260
Study start date 2006-05-01
Estimated primary completion date 2011-08-01

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