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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: 1% Clascoterone Clear all
Completed Phase 2 Interventional Results available

An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris

NCT02720627
View directory record Official record
Conditions
Acne Vulgaris
Interventions
cortexolone 17α-propionate
Drug
Lead sponsor
Cassiopea SpA
Industry
Eligibility
9 Years to 11 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
3
States / cities
Fort Smith, Arkansas • San Diego, California • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Nov 19, 2020 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 3 Interventional Results available

An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris

NCT02682264
View directory record Official record
Conditions
Acne Vulgaris
Interventions
CB-03-01 cream, 1%
Drug
Lead sponsor
Cassiopea SpA
Industry
Eligibility
9 Years and older
Enrollment
609 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
39
States / cities
Fort Smith, Arkansas • Little Rock, Arkansas • Sacramento, California + 34 more
Source: ClinicalTrials.gov public record
Updated Nov 16, 2020 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss

NCT05910450
View directory record Official record
Conditions
Alopecia, Androgenetic
Interventions
Clascoterone 5% solution, Vehicle solution
Drug
Lead sponsor
Cassiopea SpA
Industry
Eligibility
18 Years and older · Male only
Enrollment
703 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
16
States / cities
North Little Rock, Arkansas • San Diego, California • Jacksonville, Florida + 13 more
Source: ClinicalTrials.gov public record
Updated Jun 7, 2026 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 2 Interventional Results available

A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

NCT01631474
View directory record Official record
Conditions
Acne Vulgaris
Interventions
CB-03-01, Vehicle
Drug
Lead sponsor
Intrepid Therapeutics, Inc.
Industry
Eligibility
12 Years and older
Enrollment
363 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
13
States / cities
Los Angeles, California • San Diego, California • Sanford, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Nov 15, 2020 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 4 Interventional Results available

A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients

NCT06415292
View directory record Official record
Conditions
Acne Vulgaris
Interventions
Winlevi (clascoterone) 1% cream
Drug
Lead sponsor
Sun Pharmaceutical Industries Limited
Industry
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023
U.S. locations
1
States / cities
High Point, North Carolina
Source: ClinicalTrials.gov public record
Updated Mar 3, 2025 · Synced Sep 25, 2026, 10:15 AM EDT
Active, not recruiting Phase 4 Interventional

A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients

NCT06425900
View directory record Official record
Conditions
Acne Vulgaris
Interventions
Winlevi (Clascoterone) cream 1%
Drug
Lead sponsor
Sun Pharmaceutical Industries Limited
Industry
Eligibility
18 Years to 35 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
High Point, North Carolina
Source: ClinicalTrials.gov public record
Updated Jan 20, 2026 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)

NCT05914805
View directory record Official record
Conditions
Alopecia, Androgenetic
Interventions
Clascoterone 5% solution, Vehicle solution
Drug
Lead sponsor
Cassiopea SpA
Industry
Eligibility
18 Years and older · Male only
Enrollment
762 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
12
States / cities
Scottsdale, Arizona • Hollywood, Florida • Atlanta, Georgia + 9 more
Source: ClinicalTrials.gov public record
Updated Dec 21, 2025 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 4 Interventional Results available

A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne

NCT06336603
View directory record Official record
Conditions
Acne Vulgaris
Interventions
Winlevi (clascoterone) 1% & Adapalene 0.3% gel
Drug
Lead sponsor
Sun Pharmaceutical Industries Limited
Industry
Eligibility
12 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Oct 8, 2025 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)

NCT02608476
View directory record Official record
Conditions
Acne Vulgaris
Interventions
CB-03-01 cream, 1%, Vehicle cream
Drug
Lead sponsor
Cassiopea SpA
Industry
Eligibility
9 Years and older
Enrollment
732 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
12
States / cities
Scottsdale, Arizona • Fort Smith, Arkansas • Sacramento, California + 7 more
Source: ClinicalTrials.gov public record
Updated Nov 19, 2020 · Synced Sep 25, 2026, 10:15 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

NCT05891795
View directory record Official record
Conditions
Acne Vulgaris
Interventions
Clascoterone 1% Top Cream, Vehicle
Drug
Lead sponsor
Stanford University
Other
Eligibility
16 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 4 Interventional Results available

A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients

NCT06415279
View directory record Official record
Conditions
Acne Vulgaris
Interventions
Winlevi (clascoterone) 1% cream
Drug
Lead sponsor
Sun Pharmaceutical Industries Limited
Industry
Eligibility
12 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
1
States / cities
High Point, North Carolina
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Sep 25, 2026, 10:15 AM EDT
Recruiting Phase 2 Interventional

Topical Anti-Androgens in Pilonidal Sinus Disease

NCT06286397
View directory record Official record
Conditions
Pilonidal Disease, Pilonidal Disease of Natal Cleft, Pilonidal Sinus, Pilonidal Cyst
Interventions
1% Clascoterone, Vehicle Cream
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 26, 2026 · Synced Sep 25, 2026, 10:15 AM EDT
Recruiting Phase 2 Interventional Accepts healthy volunteers

Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea

NCT06952517
View directory record Official record
Conditions
Papular-pustular Rosacea, Papulopustular Rosacea (PPR), Papulopustular Rosacea
Interventions
Clascoterone Cream 1%
Drug
Lead sponsor
Narrows Institute for Biomedical Research
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025
U.S. locations
1
States / cities
Brooklyn, New York
Source: ClinicalTrials.gov public record
Updated May 5, 2025 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 4 Interventional Results available

A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne

NCT06336629
View directory record Official record
Conditions
Acne Vulgaris
Interventions
Winlevi (clascoterone) 1% & Duac gel
Drug
Lead sponsor
Sun Pharmaceutical Industries Limited
Industry
Eligibility
12 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Jul 16, 2025 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

NCT02608450
View directory record Official record
Conditions
Acne Vulgaris
Interventions
CB-03-01 cream, 1%, Vehicle cream
Drug
Lead sponsor
Cassiopea SpA
Industry
Eligibility
9 Years and older
Enrollment
708 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
44
States / cities
Little Rock, Arkansas • Fremont, California • Los Angeles, California + 34 more
Source: ClinicalTrials.gov public record
Updated Nov 19, 2020 · Synced Sep 25, 2026, 10:15 AM EDT
Completed Phase 4 Interventional Results available

A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne

NCT06415305
View directory record Official record
Conditions
Acne Vulgaris
Interventions
Winlevi (clascoterone) 1% cream
Drug
Lead sponsor
Sun Pharmaceutical Industries Limited
Industry
Eligibility
12 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Jan 15, 2026 · Synced Sep 25, 2026, 10:15 AM EDT