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Topical Gel

CLE-400 Gel for Chronic Itching

Phase 2
Recruiting
Research Sponsored by Clexio Biosciences Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a history of chronic pruritus (itch) due to Notalgia Paresthetica
Subject has a confirmed diagnosis of Notalgia Paresthetica
Must not have
Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4.

Summary

This trial is testing a new gel called CLE-400 to see if it can help with chronic itching in adults with a condition called Notalgia Paresthetica.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of CLE-400 are not detailed here but typically could include skin reactions at the application site such as redness, irritation, or rash given its nature as a topical treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have long-term itching due to Notalgia Paresthetica.
Select...
I have been diagnosed with Notalgia Paresthetica.
Select...
I experience moderate to severe itching.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change from baseline in weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 4.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CLE-400 (Detomidine topical gel)Experimental Treatment1 Intervention
Topical CLE-400 gel 0.28% once daily
Group II: VehiclePlacebo Group1 Intervention
Topical vehicle gel once daily

Find a Location

Who is running the clinical trial?

Clexio Biosciences Ltd.Lead Sponsor
2 Previous Clinical Trials
220 Total Patients Enrolled
~5 spots leftby Dec 2024
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