NCT06262607

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Clexio Biosciences Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)

Interventions

Type	Name	Description
DRUG	CLE-400	Topical CLE400 gel 0.28% administered once daily
DRUG	Vehicle	Topical vehicle gel administered once daily

Timeline

• Start date: 2024-01-29
• Primary completion: 2024-11-06
• Completion: 2024-11-19
• First posted: 2024-02-16
• Last updated: 2025-11-18
• Results posted: 2025-11-18

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study