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Topical Gel

CLE-400 (Detomidine topical gel) for Notalgia Paresthetica

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I experience moderate to severe itching.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Clexio Biosciences Ltd.Lead Sponsor

2 Previous Clinical Trials

220 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals younger than 80 years of age participate in this medical study?

"The trial is open to individuals over 18 years of age but under the age of 80."

Answered by AI

Are individuals currently able to apply and participate in this ongoing medical trial?

"Indeed, information available on clinicaltrials.gov confirms the ongoing recruitment of participants for this medical trial. The study was initially listed on January 29th, 2024, and underwent its latest update on February 8th, 2024. A total of 40 patients are sought from two distinct sites."

Answered by AI

What is the current number of participants being admitted into this research trial?

"Indeed, as per clinicaltrials.gov data, this investigation is actively seeking volunteers. The trial was first listed on January 29th, 2024 and last revised on February 8th of the same year. It aims to enroll a total of 40 patients from two distinct locations."

Answered by AI

Is it possible for me to be enrolled as a participant in this medical study?

"To qualify for participation in this research, individuals must exhibit notalgia paresthetica and fall within the age range of 18 to 80 years. The study aims to enroll approximately 40 subjects."

Answered by AI

What are the associated risks of using CLE-400 (Detomidine topical gel) in individuals?

"The safety evaluation of CLE-400 (Detomidine topical gel) at Power is rated a 2, reflecting the ongoing Phase 2 trial status. While data confirms some level of safety, efficacy evidence is yet to be established."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06262607.

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