At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
CLE-400 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-400 Topical Gel for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica
In Brief
A Phase 2 clinical trial evaluating CLE-400 and Vehicle for Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP). Completed, enrolled 59 participants across 13 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202420252026
Enrollment StartJan 2024
First PostedFeb 2024
Primary CompletionNov 2024
Study CompletionNov 2024
TodayJul 2026
First PostedFeb 16, 2024
Enrollment StartJan 29, 2024
Primary CompletionNov 6, 2024
Study CompletionNov 19, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.4 years ago
Interventions
CLE-400drug
Topical CLE400 gel 0.28% administered once daily
Vehicledrug
Topical vehicle gel administered once daily