A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects with Notalgia Paresthetica
- Conditions
- Chronic Pruritus in Adult Subjects with Notalgia Paresthetica (NP)
- Interventions
- Drug: Vehicle
- Registration Number
- NCT06262607
- Lead Sponsor
- Clexio Biosciences Ltd.
- Brief Summary
This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP).
- Detailed Description
Study to assess the efficacy and safety of CLE-400 topical gel applied once daily for the treatment of moderate-severe chronic pruritus in adult subjects with NP. The study comprises a screening phase of up to 37 days, including a 7-day run-in period, a 4-week double-blind treatment period, and a 2-week follow-up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- Subject has a confirmed diagnosis of Notalgia Paresthetica.
- Subject has a history of chronic pruritus (itch) due to Notalgia Paresthetica.
- Subject has moderate to severe pruritus.
- Subject is able and competent to read and sign the informed consent form (ICF).
- Subject has chronic pruritus that is related to a condition other than Notalgia Paresthetica.
- Subject with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, including physical/laboratory/ECG/vital signs abnormality that would put the subject at undue risk or interfere with interpretation of study results
- Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CLE-400 (Detomidine topical gel) CLE-400 Topical CLE-400 gel 0.28% once daily Vehicle Vehicle Topical vehicle gel once daily
- Primary Outcome Measures
Name Time Method Percent change from baseline in weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 4. Baseline, Week 4. The WI-NRS is a scale from 0 to 10, where a higher value represents a worse outcome
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Clinical site 11
🇺🇸Bryant, Arkansas, United States
Clinical Site 21
🇺🇸Fremont, California, United States
Clinical site 01
🇺🇸Coral Gables, Florida, United States
Clinical Site 13
🇺🇸Margate, Florida, United States
Clinical Site 10
🇺🇸North Miami Beach, Florida, United States
Clinical Site 02
🇺🇸Indianapolis, Indiana, United States
Clinical Site 23
🇺🇸Methuen, Massachusetts, United States
Clinical Site 20
🇺🇸Portsmouth, New Hampshire, United States
Clinical Site 15
🇺🇸New York, New York, United States
Clinical site 03
🇺🇸High Point, North Carolina, United States
Clinical Site 09
🇺🇸Dublin, Ohio, United States
Clinical site 16
🇺🇸Houston, Texas, United States
Clinical Site 06
🇺🇸San Antonio, Texas, United States