Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL
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|ClinicalTrials.gov Identifier: NCT02811783|
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : March 11, 2020
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 2021|
|Estimated Study Completion Date :||August 2021|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811783
|Contact: Scott B Phillips, MDfirstname.lastname@example.org|
|Contact: Heidi Fezatte, BSemail@example.com|
|Study Director:||Scott B Phillips, MD||Elorac, Inc.|