Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
|ClinicalTrials.gov Identifier: NCT02811783|
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : March 2, 2018
This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing.
Funding Source - FDA OOPD
|Condition or disease||Intervention/treatment||Phase|
|Mycosis Fungoides Lymphoma, T-Cell, Cutaneous Sézary Syndrome||Drug: Naloxone Hydrochloride Lotion, 0.5% Drug: Placebo Lotion||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Randomized Vehicle Controlled Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients With the MF or SS Forms of Cutaneous T-Cell Lymphoma|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||August 2019|
Active Comparator: Naloxone Hydrochloride Lotion, 0.5%
Naloxone Hydrochloride Lotion 0.5%
Drug: Naloxone Hydrochloride Lotion, 0.5%
Topical TID for 2 weeks
Placebo Comparator: Placebo Lotion
Drug: Placebo Lotion
Topical TID for 2 weeks
- Numeric Rating Scale (NRS) for Pruritus [ Time Frame: Baseline and 2 Weeks ]Change from Baseline to Day 14 in average NRS for Pruritus for each Treatment Period
- Responder Analysis - The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods. [ Time Frame: Baseline and 2 Weeks ]The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods. A clinically significant improvement is defined as an improvement of at least one category on the 4-point (none, mild, moderate, severe) Likert Scale verbal rating scale (VRS) and at least two points on the 11-point NRS for Pruritus. The NRS for Pruritus scores will be converted to VRS scores as follows for the analysis: 0=none, 1-3=mild, 4-6=moderate, and 7-10=severe.
- Numeric Rating Scale for Sleep [ Time Frame: Baseline and 1 and 2 weeks ]The change from Baseline at each week of the NRS for Sleep average score for each Treatment Period.
- Numeric Rating Scale for Pruritus [ Time Frame: Baseline and 1 week ]The change from Baseline at Week 1 of the NRS for Pruritus average score for each Treatment Period.
- Categorical Rating Scale (CRS) for Skin Integrity [ Time Frame: Baseline and 2 weeks ]The change from Baseline at Week 2 of the CRS for Skin Integrity for each Treatment Period.
- Pruritus Quality of Life Score (PQOL) [ Time Frame: Baseline and Day 14 of each Treatment period ]The change from Baseline in the final categorization of the PQOL at Day 14 of each Treatment Period
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811783
|Contact: Scott B Phillips, MDemail@example.com|
|Contact: Heidi Fezatte, BSfirstname.lastname@example.org|
Show 21 Study Locations
|Study Director:||Scott B Phillips, MD||Elorac, Inc.|