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

Completed · Phase 2

Conditions studied: Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)

In brief

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).

Key facts

Study ID

NCT06262607

Run by

Clexio Biosciences Ltd.

People needed

59

Starts

2024-01-29

Expected to finish

2024-11-19

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Clinical site 11 — Bryant, Arkansas, United States
• Clinical Site 21 — Fremont, California, United States
• Clinical site 01 — Coral Gables, Florida, United States
• Clinical Site 13 — Margate, Florida, United States
• Clinical Site 10 — North Miami Beach, Florida, United States
• Clinical Site 02 — Indianapolis, Indiana, United States
• Clinical Site 23 — Methuen, Massachusetts, United States
• Clinical Site 20 — Portsmouth, New Hampshire, United States
• Clinical Site 15 — New York, New York, United States
• Clinical site 03 — High Point, North Carolina, United States
• Clinical Site 09 — Dublin, Ohio, United States
• Clinical site 16 — Houston, Texas, United States
• Clinical Site 06 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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