14 completed, 4 recruiting, 2 active not recruiting, 1 not yet recruiting. 7 Phase 2, 7 Phase 4, 6 Phase 3, 1 Not applicable, 1 Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clascoterone Versus Clindamycin Added to Adapalene/Benzoyl Peroxide for Moderate Facial Acne Clascoterone 1% cream, Clindamycin 1% lotion, Adapalene 0.1%/benzoyl peroxide 2.5% gel - Acne Vulgaris | Phase 4 | Not yet recruiting | Allied Hospital Faisalabad | 118 | 2026-11-01 | 2026-10-19 |
| Comparison of Topical Clascoterone 1% Cream Versus Adapalene 0.1% Cream in the Treatment of Mild-to-Moderate Acne Vulgaris Clascoterone 1% cream, Adapalene 0.1% cream - Acne Vulgaris | Not applicable | Recruiting | Pak Emirates Military Hospital | 130 | 2026-10-08 | 2026-10-22 |
| Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea Clascoterone Cream 1% - Papular-pustular Rosacea, Papulopustular Rosacea (PPR) | Phase 2 | Recruiting | Narrows Institute for Biomedical Research | 20 | 2025-03-14 | 2025-05-06 |
| Topical Anti-Androgens in Pilonidal Sinus Disease 1% Clascoterone, Vehicle Cream - Pilonidal Disease, Pilonidal Disease of Natal Cleft | Phase 2 | Recruiting | University of Pennsylvania | 75 | 2025-01-10 | 2026-02-27 |
| Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy Clascoterone 1% Top Cream, Vehicle - Acne Vulgaris | Phase 1 / Phase 2 | Active not recruiting | Stanford University | 18 | 2024-07-22 | 2026-04-30 |
| A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients Winlevi (Clascoterone) cream 1% - Acne Vulgaris | Phase 4 | Active not recruiting | Sun Pharmaceutical Industries Limited | 10 | 2024-07-01 | 2026-01-21 |
| Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris Clascoterone, Vehicle cream - Acne Vulgaris | Phase 3 | Recruiting | Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | 692 | 2024-05-20 | 2025-07-09 |
| A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients Winlevi (clascoterone) 1% cream - Acne Vulgaris | Phase 4 | Completed | Sun Pharmaceutical Industries Limited | 40 | 2024-02-14 | 2026-06-15 |
| A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients Winlevi (clascoterone) 1% cream - Acne Vulgaris | Phase 4 | Completed | Sun Pharmaceutical Industries Limited | 50 | 2023-11-27 | 2025-03-04 |
| 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 Winlevi (clascoterone) 1% & Duac gel - Acne Vulgaris | Phase 4 | Completed | Sun Pharmaceutical Industries Limited | 10 | 2023-11-15 | 2025-07-17 |
| A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne Winlevi (clascoterone) 1% & Adapalene 0.3% gel - Acne Vulgaris | Phase 4 | Completed | Sun Pharmaceutical Industries Limited | 20 | 2023-11-15 | 2025-10-09 |
| A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne Winlevi (clascoterone) 1% cream - Acne Vulgaris | Phase 4 | Completed | Sun Pharmaceutical Industries Limited | 10 | 2023-09-01 | 2026-01-16 |
| A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) Clascoterone 5% solution, Vehicle solution - Alopecia, Androgenetic | Phase 3 | Completed | Cassiopea SpA | 762 | 2023-08-17 | 2025-12-22 |
| A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss Clascoterone 5% solution, Vehicle solution - Alopecia, Androgenetic | Phase 3 | Completed | Cassiopea SpA | 703 | 2023-06-21 | 2026-06-08 |
| An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris cortexolone 17α-propionate - Acne Vulgaris | Phase 2 | Completed | Cassiopea SpA | 27 | 2016-10-28 | 2020-11-20 |
| An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris CB-03-01 cream, 1% - Acne Vulgaris | Phase 3 | Completed | Cassiopea SpA | 609 | 2016-03-09 | 2020-11-17 |
| A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25) CB-03-01 cream, 1%, Vehicle cream - Acne Vulgaris | Phase 3 | Completed | Cassiopea SpA | 708 | 2016-01-21 | 2020-11-20 |
| A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26) CB-03-01 cream, 1%, Vehicle cream - Acne Vulgaris | Phase 3 | Completed | Cassiopea SpA | 732 | 2015-11-16 | 2020-11-20 |
| A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia CB-03-01 solution, Minoxidil Solution 5%, Placebo solution - Androgenetic Alopecia | Phase 2 | Completed | Intrepid Therapeutics, Inc. | 95 | 2014-10-01 | 2017-03-13 |
| An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris cortexolone 17α-propionate - Acne Vulgaris | Phase 2 | Completed | Intrepid Therapeutics, Inc. | 42 | 2013-04-01 | 2020-12-02 |
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Acne Vulgaris (16) · Alopecia (3) · Pilonidal Sinus (1) · Rosacea (1)
Cassiopea SpA (6) · Sun Pharmaceutical Industries Limited (6) · Intrepid Therapeutics, Inc. (3) · Allied Hospital Faisalabad (1) · Narrows Institute for Biomedical Research (1) · Pak Emirates Military Hospital (1) · Stanford University (1) · University of Pennsylvania (1) · Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. (1)
United States (18) · Georgia (4) · Poland (4) · Bulgaria (2) · Pakistan (2) · Romania (2) · Serbia (2) · Ukraine (2) · China (1) · Germany (1)
Alessandro Mazzetti, M.D. (2) · Anne Lynn S Chang, MD (1) · Anthony Andrasfay (1) · Jared Jagdeo, MD MS (1)
PMID 32320027, PMID 34607697, PMID 36745367, PMID 38206145, PMID 40682762