Completed

NCT Number: NCT06262607

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

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).

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Key information

Conditions

Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical site 11, Bryant, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.

Treatment and study plan

CLE-400

Drug

Topical CLE400 gel 0.28% administered once daily

Vehicle

Drug

Topical vehicle gel administered once daily

Primary outcomes

Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4.

Time frame: Baseline, Week 4 (28 days).

The WI-NRS is a tool used to assess the intensity of the most severe (worst) pruritus (itch), as experienced by the subject, in the last 24 hours. WI-NRS scale score ranges from 0 to 10, with 0 indicating no itch and 10 indicating the worst itch imaginable.

Sponsors and collaborators

Lead sponsor

Clexio Biosciences Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Feb 16, 2024
Registry last updated: Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.