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

Clexio Biosciences Ltd.59 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)

Interventions

CLE-400DRUG

Topical CLE400 gel 0.28% administered once daily

VehicleDRUG

Topical vehicle gel administered once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (13)

Clinical site 11

Bryant, Arkansas, United States

Clinical Site 21

Fremont, California, United States

Clinical site 01

Coral Gables, Florida, United States

Outcomes

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.

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.

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

Data from ClinicalTrials.gov

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