- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06415292
A Study to Evaluate the Impact of Clacoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients
May 10, 2024 updated by: Sun Pharmaceutical Industries Limited
A Clinical Study to Assess the Barrier Impact of Winlevi
Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance.
Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect.
A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties.
The barrier properties of 1% clascoterone have never been demonstrated.
This study is aimed at better understanding the positive barrier effects of 1% clascoterone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
High Point, North Carolina, United States, 27262
- Dermatology Consulting Services, PLLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Subjects who self identify as having sensitive acne prone skin.
- Female or male subjects 18+ years of age.
- Subjects with Fitzpatrick skin types I-VI.
- Subject agrees not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, powder) or skin care products during the study.
- Subjects must be willing to use only a cleanser and sunscreen on the entire face and no other skin care products.
- Subjects must be willing to use the Winlevi study product to designated half face. No other topical acne treatment products on the entire face for the 2 week duration of the study.
- Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
- Subject is dependable and able to follow directions and is willing to comply with the schedule of visits.
- Subject is in generally good physical and mental health.
Exclusion Criteria:
- Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the conditions associated with sensitive skin.
- Subjects who are not willing to use only the assigned study product and nothing else one randomized half face, except for cleanser and sunscreen that must remain unchanged during the study. Moisturizers or topical acne treatment products should not be used during the 2 week study period on either side of the face.
- Subjects who do not agree to refrain from direct sun exposure during the study duration.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Subjects, who are pregnant, breast feeding, or planning a pregnancy.
- Subjects with clinically significant unstable medical disorders.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- Subjects who are currently participating in any other clinical study.
- Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.
- Subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day.
- Subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the initial paperwork.
- Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara) and/or radiation as determined by study documentation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Winlevi (clascoterone) 1% treated
|
Split face.
Blinded study treatment product to be applied to the randomized half face
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is the change in corneometry reading between the two sides of the face treated with Winlevi versus no treatment.
Time Frame: Week 2
|
Week 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary endpoint is the change in TEWL reading between the two sides of the face treated with Winlevi versus no treatment
Time Frame: Week 2
|
Week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2023
Primary Completion (Actual)
December 16, 2023
Study Completion (Actual)
December 16, 2023
Study Registration Dates
First Submitted
May 10, 2024
First Submitted That Met QC Criteria
May 10, 2024
First Posted (Actual)
May 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 10, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCS-94-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Cassiopea SpACompletedAcne VulgarisUnited States, Bulgaria, Romania, Serbia, Georgia, Poland, Ukraine