CompletedPhase 2

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

United States59 participantsStarted 2024-01-29

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline, Week 4 (28 days).

Trial details

NCT IDNCT06262607

SponsorClexio Biosciences Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-06

Results submitted2025-11-06

View on ClinicalTrials.gov More Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP) trials