A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica
NCT ID: NCT06262607
Last Updated: 2025-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2024-01-29
2024-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CLE-400 (Detomidine topical gel)
Topical CLE-400 gel 0.28% once daily
CLE-400
Topical CLE400 gel 0.28% administered once daily
Vehicle
Topical vehicle gel once daily
Vehicle
Topical vehicle gel administered once daily
Interventions
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CLE-400
Topical CLE400 gel 0.28% administered once daily
Vehicle
Topical vehicle gel administered once daily
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Clexio Biosciences Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLE400-NP-201
Identifier Type: -
Identifier Source: org_study_id
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