CLE-400 Gel for Chronic Itching
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new gel called CLE-400 (Detomidine topical gel) to evaluate its effectiveness for people with Notalgia Paresthetica, a condition that causes chronic itching. Researchers aim to determine if this gel can reduce itching and if it is safe to use. Participants will apply either the CLE-400 gel or a placebo gel (a gel with no active medicine) once a day. The trial seeks individuals experiencing moderate to severe itching due to Notalgia Paresthetica. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that CLE-400 gel is likely to be safe for humans?
Research shows that CLE-400, a gel applied to the skin containing detomidine, is being tested for safety in humans. Past studies with similar treatments have generally been well-tolerated for other conditions. So far, no specific reports of serious side effects have emerged with CLE-400. This Phase 2 trial focuses on assessing both the safety and effectiveness of the gel. At this stage, researchers test the treatment on more people to better understand its safety and identify any side effects.
As with any new treatment, some risks might exist, but current findings suggest CLE-400 appears promising. Participants in clinical trials like this one help researchers gather important safety information for future use.12345Why do researchers think this study treatment might be promising for chronic itching?
Unlike the standard treatments for chronic itching, which often involve antihistamines or corticosteroids, CLE-400 gel utilizes detomidine, a topical gel formulation. What makes CLE-400 stand out is its potential to target itching more directly through its novel application as a daily topical gel, offering a new approach compared to oral or systemic treatments. Researchers are particularly excited about this treatment because its unique delivery method might provide relief with fewer systemic side effects and more focused action on the affected skin areas.
What evidence suggests that CLE-400 gel might be an effective treatment for chronic itching?
Research has shown that CLE-400 gel, containing detomidine, may help treat chronic itching. Detomidine affects certain receptors in the body to reduce itchiness. Early results suggest that people using CLE-400 experienced much better symptom relief than those using a vehicle gel. Studies on similar treatments have also shown they can help with long-term skin conditions. This evidence suggests that CLE-400 could be a promising option for people with conditions like Notalgia Paresthetica, which causes ongoing itching.12567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CLE-400 topical gel or placebo once daily for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CLE-400
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clexio Biosciences Ltd.
Lead Sponsor