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

NCT06262607 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CLE400-NP-201
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

CLE-400 (Detomidine topical gel)

EXPERIMENTAL

Topical CLE-400 gel 0.28% once daily

Drug: CLE-400

Vehicle

PLACEBO COMPARATOR

Topical vehicle gel once daily

Drug: Vehicle

Interventions

CLE-400 DRUG

Topical CLE400 gel 0.28% administered once daily

CLE-400 (Detomidine topical gel)

Vehicle DRUG

Topical vehicle gel administered once daily

Vehicle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clexio Biosciences Ltd.: lead

Study Sites (13)

Clinical site 11

Bryant, Arkansas, 72022, United States

Location

Clinical Site 21

Fremont, California, 94538, United States

Location

Clinical site 01

Coral Gables, Florida, 33134, United States

Location

Clinical Site 13

Margate, Florida, 33063, United States

Location

Clinical Site 10

North Miami Beach, Florida, 33116, United States

Location

Clinical Site 02

Indianapolis, Indiana, 46250, United States

Location

Clinical Site 23

Methuen, Massachusetts, 01844, United States

Location

Clinical Site 20

Portsmouth, New Hampshire, 03801, United States

Location

Clinical Site 15

New York, New York, 10028, United States

Location

Clinical site 03

High Point, North Carolina, 27262, United States

Location

Clinical Site 09

Dublin, Ohio, 43016, United States

Location

Clinical site 16

Houston, Texas, 77004, United States

Location

Clinical Site 06

San Antonio, Texas, 78213, United States

Location

Results Point of Contact

• Title: Regulatory Affairs Lead
• Organization: Clexio Biosciences Ltd

myriam.belahcen@clexio.com

972-733318704

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 54 subjects, 2 arms, parallel

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: January 29, 2024
• Primary Completion: November 6, 2024
• Study Completion: November 19, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Locations

US (13)