CLE-400 Gel for Chronic Itching

Recruiting at 12 trial locations

Overseen By Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Clexio Biosciences Ltd.

Disqualifiers: Systemic disease, Unstable disorders, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

59 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

Adults with chronic itching due to Notalgia Paresthetica (NP) can join this study. They must have a confirmed NP diagnosis and moderate to severe itchiness, be able to consent, and not be pregnant or planning pregnancy during the trial. Those with other causes of itch or significant health issues are excluded.

Inclusion Criteria

I have long-term itching due to Notalgia Paresthetica.

Subject is able and competent to read and sign the informed consent form (ICF)

I have been diagnosed with Notalgia Paresthetica.

Exclusion Criteria

I have long-term itching not caused by Notalgia Paresthetica.

I do not have any severe illnesses that could risk my participation in the study.

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Includes a 7-day run-in period

Treatment

Participants receive CLE-400 topical gel or placebo once daily for 4 weeks

4 weeks

Daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CLE-400

Trial Overview The trial is testing CLE-400 topical gel against a placebo (vehicle) gel to see if it's effective and safe for treating long-term itching in adults with NP. Participants will be randomly assigned to receive either the test gel or placebo in a blinded manner.

How Is the Trial Designed?

Group I: CLE-400 (Detomidine topical gel) Experimental Treatment 1 Intervention

Topical CLE-400 gel 0.28% once daily

Group II: Vehicle Placebo Group 1 Intervention

Topical vehicle gel once daily

Who Is Running the Clinical Trial?

Clexio Biosciences Ltd.

Lead Sponsor

Trials

3

Recruited

280+