Trial Outcomes & Findings for A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NCT NCT06262607)
NCT ID: NCT06262607
Last Updated: 2025-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Baseline, Week 4 (28 days).
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
CLE-400 (Detomidine Topical Gel)
Topical CLE-400 gel 0.28% once daily
CLE-400: Topical CLE400 gel 0.28% administered once daily
|
Vehicle
Topical vehicle gel once daily
Vehicle: Topical vehicle gel administered once daily
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
31
|
|
Overall Study
COMPLETED
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
CLE-400 (Detomidine Topical Gel)
Topical CLE-400 gel 0.28% once daily
CLE-400: Topical CLE400 gel 0.28% administered once daily
|
Vehicle
Topical vehicle gel once daily
Vehicle: Topical vehicle gel administered once daily
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica
Baseline characteristics by cohort
| Measure |
CLE-400 (Detomidine Topical Gel)
n=28 Participants
Topical CLE-400 gel 0.28% once daily
CLE-400: Topical CLE400 gel 0.28% administered once daily
|
Vehicle
n=31 Participants
Topical vehicle gel once daily
Vehicle: Topical vehicle gel administered once daily
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=202 Participants
|
20 Participants
n=283 Participants
|
38 Participants
n=120 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=202 Participants
|
11 Participants
n=283 Participants
|
21 Participants
n=120 Participants
|
|
Age, Continuous
|
61.82 years
STANDARD_DEVIATION 8.2 • n=202 Participants
|
60.48 years
STANDARD_DEVIATION 10.5 • n=283 Participants
|
61.12 years
STANDARD_DEVIATION 9.4 • n=120 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=202 Participants
|
24 Participants
n=283 Participants
|
45 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=202 Participants
|
7 Participants
n=283 Participants
|
14 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=202 Participants
|
11 Participants
n=283 Participants
|
22 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=202 Participants
|
20 Participants
n=283 Participants
|
37 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=202 Participants
|
29 Participants
n=283 Participants
|
56 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=202 Participants
|
31 participants
n=283 Participants
|
59 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4 (28 days).Population: 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.
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.
Outcome measures
| Measure |
CLE-400 (Detomidine Topical Gel)
n=28 Participants
Topical CLE-400 gel 0.28% once daily
CLE-400: Topical CLE400 gel 0.28% administered once daily
|
Vehicle
n=31 Participants
Topical vehicle gel once daily
Vehicle: Topical vehicle gel administered once daily
|
|---|---|---|
|
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 percentage of change from baseline
Standard Error 5.75
|
-50.37 percentage of change from baseline
Standard Error 5.43
|
Adverse Events
CLE-400 (Detomidine Topical Gel)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CLE-400 (Detomidine Topical Gel)
n=28 participants at risk
Topical CLE-400 gel 0.28% once daily
CLE-400: Topical CLE400 gel 0.28% administered once daily
|
Vehicle
n=31 participants at risk
Topical vehicle gel once daily
Vehicle: Topical vehicle gel administered once daily
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/28 • 6 weeks after participant received first dose
|
3.2%
1/31 • Number of events 1 • 6 weeks after participant received first dose
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • Number of events 2 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
|
Injury, poisoning and procedural complications
Concussion
|
3.6%
1/28 • Number of events 1 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/28 • 6 weeks after participant received first dose
|
3.2%
1/31 • Number of events 1 • 6 weeks after participant received first dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/28 • 6 weeks after participant received first dose
|
3.2%
1/31 • Number of events 1 • 6 weeks after participant received first dose
|
|
Nervous system disorders
Somnolence
|
3.6%
1/28 • Number of events 1 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/28 • 6 weeks after participant received first dose
|
3.2%
1/31 • Number of events 1 • 6 weeks after participant received first dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.6%
1/28 • Number of events 1 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
3.6%
1/28 • Number of events 1 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
|
General disorders
Application site paraesthesia
|
3.6%
1/28 • Number of events 1 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
|
General disorders
Influenza like illness
|
3.6%
1/28 • Number of events 1 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
|
General disorders
Xerosis
|
0.00%
0/28 • 6 weeks after participant received first dose
|
3.2%
1/31 • Number of events 1 • 6 weeks after participant received first dose
|
|
Infections and infestations
Pyuria
|
0.00%
0/28 • 6 weeks after participant received first dose
|
3.2%
1/31 • Number of events 1 • 6 weeks after participant received first dose
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Number of events 1 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
|
Infections and infestations
Tooth abscess
|
3.6%
1/28 • Number of events 1 • 6 weeks after participant received first dose
|
0.00%
0/31 • 6 weeks after participant received first dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the multicenter publication or 18 months after completion of the Study, whichever occurs first, Institution may itself publish the results of its data from the Study. Institution and Principal Investigator shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER