A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica

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).

Timeline

Start

2024-01-29

Primary completion

2024-11-06

Completion

2024-11-19

Outcome

Missed primary endpoint

registry analysis (superiority test); CLE-400 (Detomidine Topical Gel) vs Vehicle; p = 0.4422; Least square (LS) mean difference 6.0 (95% CI -9.54 to 21.53); NCT06262607 ↗

Drugs

Indications