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

Last updated: December 19, 2024
Sponsor: Clexio Biosciences Ltd.
Overall Status: Completed

Phase

2

Condition

Rash

Hives (Urticaria)

Skin Wounds

Treatment

CLE-400

Vehicle

Clinical Study ID

NCT06262607
CLE400-NP-201
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Subject has chronic pruritus that is related to a condition other than NotalgiaParesthetica.

  • Subject with known or suspected history of a clinically significant systemicdisease, unstable medical disorders, life-threatening disease, includingphysical/laboratory/ECG/vital signs abnormality that would put the subject at unduerisk or interfere with interpretation of study results

  • Subject is a female who is breastfeeding, pregnant, or who is planning to becomepregnant during the study.

Study Design

Total Participants: 59
Treatment Group(s): 2
Primary Treatment: CLE-400
Phase: 2
Study Start date:
January 29, 2024
Estimated Completion Date:
November 19, 2024

Study 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.

Connect with a study center

  • Clinical site 11

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Clinical Site 21

    Fremont, California 94538
    United States

    Site Not Available

  • Clinical site 01

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Clinical Site 13

    Margate, Florida 33063
    United States

    Site Not Available

  • Clinical Site 10

    North Miami Beach, Florida 33116
    United States

    Site Not Available

  • Clinical Site 02

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Clinical Site 23

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Clinical Site 20

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Clinical Site 15

    New York, New York 10028
    United States

    Site Not Available

  • Clinical site 03

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Clinical Site 09

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Clinical site 16

    Houston, Texas 77004
    United States

    Site Not Available

  • Clinical Site 06

    San Antonio, Texas 78213
    United States

    Site Not Available

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