Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
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 |