Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)Phase 2NCT06262607

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

A Phase 2 study testing CLE-400 in people with Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP), run by Clexio Biosciences Ltd. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)
What is being tested?: CLE-400
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 59 participants
Where: 13 sitesUnited States
Study dates: 29 Jan 2024to 19 Nov 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Clinical site 11
Bryant, Arkansas, 72022
Clinical site 01
Coral Gables, Florida, 33134
Clinical Site 09
Dublin, Ohio, 43016
Clinical Site 21
Fremont, California, 94538
Clinical site 03
High Point, North Carolina, 27262
Clinical site 16
Houston, Texas, 77004
Clinical Site 02
Indianapolis, Indiana, 46250
Clinical Site 13
Margate, Florida, 33063
Clinical Site 23
Methuen, Massachusetts, 01844
Clinical Site 15
New York, New York, 10028
Clinical Site 10
North Miami Beach, Florida, 33116
Clinical Site 20
Portsmouth, New Hampshire, 03801
Clinical Site 06
San Antonio, Texas, 78213

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-400 Topical Gel for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica

Read the detailed description

Study to assess the efficacy and safety of CLE-400 topical gel applied once daily for the treatment of moderate-severe chronic pruritus in adult subjects with NP. The study comprises a screening phase of up to 37 days, including a 7-day run-in period, a 4-week double-blind treatment period, and a 2-week follow-up period.

Conditions: Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)
Being tested: CLE-400, Vehicle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CLE-400Drug
Topical CLE400 gel 0.28% administered once daily
VehicleDrug
Topical vehicle gel administered once daily

Study groups in NCT06262607
Study group	Role	What they receive
CLE-400 (Detomidine topical gel)	Experimental	Topical CLE-400 gel 0.28% once daily Receives: Drug: CLE-400
Vehicle	Placebo comparator	Topical vehicle gel once daily Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4.
The WI-NRS is a tool used to assess the intensity of the most severe (worst) pruritus (itch), as experienced by the subject, in the last 24 hours. WI-NRS scale score ranges from 0 to 10, with 0 indicating no itch and 10 indicating the worst itch imaginable.
Measured: Baseline, Week 4 (28 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 202419 Nov 2024

First posted16 Feb 2024
Study start29 Jan 2024
Primary completion6 Nov 2024
Study completion19 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 54 subjects, 2 arms, parallel
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06262607
Sponsor's protocol ID: CLE400-NP-201
Status last verified: Nov 2025
First submitted: 8 Feb 2024
Last updated: 18 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-400 Topical Gel for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica
ClinicalTrials.gov ID: NCT06262607
Acronym / sponsor ID: CLE400-NP-201
Conditions: Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Clexio Biosciences Ltd.Industry (pharma, biotech, devices)
Study start: 29 Jan 2024 (actual)
Primary completion: 6 Nov 2024 (actual)
Study completion: 19 Nov 2024 (actual)
First posted: 16 Feb 2024 (actual)
Results: Posted 18 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: 54 subjects, 2 arms, parallel

Arm	Type	Receives
CLE-400 (Detomidine topical gel)	Experimental	Drug: CLE-400Topical CLE-400 gel 0.28% once daily
Vehicle	Placebo comparator	Drug: VehicleTopical vehicle gel once daily

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CLE-400Topical CLE400 gel 0.28% administered once daily	Drug	CLE-400 (Detomidine topical gel)
VehicleTopical vehicle gel administered once daily	Drug	Vehicle

Primary outcome

Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4.
Time frame: Baseline, Week 4 (28 days).
The WI-NRS is a tool used to assess the intensity of the most severe (worst) pruritus (itch), as experienced by the subject, in the last 24 hours. WI-NRS scale score ranges from 0 to 10, with 0 indicating no itch and 10 indicating the worst itch imaginable.

Results and safety

Results posted to the registry on 18 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CLE-400 (Detomidine Topical Gel)	28	26
Vehicle	31	30

Primary outcome: Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4.

Time frame: Baseline, Week 4 (28 days).. Least squares mean (Standard Error). Unit: percentage of change from baseline

Measure	CLE-400 (Detomidine Topical Gel) n = 28	Vehicle n = 31
Value	-44.37 (5.75)	-50.37 (5.43)

CLE-400 (Detomidine Topical Gel) vs Vehicle: Least square (LS) mean difference: 6.0 (95% CI -9.54 to 21.53), p = 0.4422, Mixed Models Repeated Measures (MMRM)

Population analysed: The FAS is a subset of the ITT analysis set and will include all randomized subjects who received at least 1 dose of study treatment and have both baseline and at least one post-baseline weekly mean WI-NRS evaluation. In this analysis set, treatment is assigned based on the treatment to which subjects were randomized, regardless of which treatment they actually received. The FAS serves as the principal analysis set for efficacy inference.

Adverse events

Time frame: 6 weeks after participant received first dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CLE-400 (Detomidine Topical Gel)	0 of 28 (0%)	8 of 28 (28.6%)	0 of 28
Vehicle	0 of 31 (0%)	5 of 31 (16.1%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CLE-400 in people with Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP), run by Clexio Biosciences Ltd. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) Score at Week 4. (time frame: Baseline, Week 4 (28 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06262607.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.