Phase 2
N=59
A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica
Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)
Bottom Line
View on ClinicalTrials.gov: NCT06262607 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4. — -44.37; -50.37 percentage of change from baseline — p=0.4422
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CLE-400 (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clexio Biosciences Ltd.
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4. |
-44.37; -50.37 | 0.4422 |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06262607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.