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

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 Overview

• Status: Completed
• Conditions: Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)
• Intervention / Treatment: Drug: CLE-400; Drug: Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Clinical Site 11
  • California
    • Fremont, California, United States, 94538
      • Clinical Site 21
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Site 01
    • Margate, Florida, United States, 33063
      • Clinical Site 13
    • North Miami Beach, Florida, United States, 33116
      • Clinical Site 10
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Clinical Site 02
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • Clinical Site 23
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Clinical Site 20
  • New York
    • New York, New York, United States, 10028
      • Clinical Site 15
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Clinical Site 03
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Clinical Site 09
  • Texas
    • Houston, Texas, United States, 77004
      • Clinical Site 16
    • San Antonio, Texas, United States, 78213
      • Clinical Site 06

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLE-400 (Detomidine topical gel); Topical CLE-400 gel 0.28% once daily	Drug: CLE-400; Topical CLE400 gel 0.28% administered once daily
Placebo Comparator: Vehicle; Topical vehicle gel once daily	Drug: Vehicle; Topical vehicle gel administered once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 4 (28 days).

Collaborators and Investigators

• Sponsor: Clexio Biosciences Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Skin Manifestations; Skin Diseases; Back Pain; Pruritus
• Other Study ID Numbers: CLE400-NP-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No