A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Not… (NCT06262607) | Clinical Trial Compass
CompletedPhase 2
A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica
United States59 participantsStarted 2024-01-29
Plain-language 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).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Criteria:
* Subject has chronic pruritus that is related to a condition other than Notalgia Paresthetica.
* Subject with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, including physical/laboratory/ECG/vital signs abnormality that would put the subject at undue risk or interfere with interpretation of study results
* Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4.