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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02811783
Other study ID # EL-1007-01-01
Secondary ID 1R01FD005396-01A
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 2017
Est. completion date September 2022

Study information

Verified date October 2022
Source Elorac, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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Study Design


Intervention

Drug:
Naloxone Hydrochloride Lotion, 0.5%
Topical TID for 2 weeks
Placebo Lotion
Topical TID for 2 weeks

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Sponsors (1)

Lead Sponsor Collaborator
Elorac, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Rating Scale (NRS) for Pruritus Change from Baseline to Day 14 in average NRS for Pruritus for each Treatment Period Baseline and 2 Weeks
Secondary Responder Analysis - The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods. 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. Baseline and 2 Weeks
Secondary Numeric Rating Scale for Sleep The change from Baseline at each week of the NRS for Sleep average score for each Treatment Period. Baseline and 1 and 2 weeks
Secondary Numeric Rating Scale for Pruritus The change from Baseline at Week 1 of the NRS for Pruritus average score for each Treatment Period. Baseline and 1 week
Secondary Categorical Rating Scale (CRS) for Skin Integrity The change from Baseline at Week 2 of the CRS for Skin Integrity for each Treatment Period. Baseline and 2 weeks
Secondary Pruritus Quality of Life Score (PQOL) The change from Baseline in the final categorization of the PQOL at Day 14 of each Treatment Period Baseline and Day 14 of each Treatment period
See also
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