Winlevi (clascoterone cream 1%) / Cosmo Pharma, Glenmark - LARVOL DELTA

A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients (clinicaltrials.gov) - P4 | N=40 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

Improvement in Skin Moisturization and Lack of Barrier Damage Following Treatment With Clascoterone Cream 1. (PubMed, J Drugs Dermatol) - "Twice-daily treatment with clascoterone cream 1% for 2 weeks was associated with increased moisturization and maintenance of skin barrier function as assessed by corneometry and TEWL and was otherwise well tolerated. J Drugs Dermatol. 2025;24(4):397-402. doi:10.36849/JDD.8774."

Journal • Acne Vulgaris • Dermatology

A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

Four years of study by an expert group on truncal acne: where are we now? (PubMed, Eur J Dermatol) - "Truncal acne has significantly gained interest over recent years, and novel assessment tools and treatments are available to manage this condition efficiently. However, international treatment guidelines require updating, considering the importance of truncal acne."

Journal • Review • Acne Vulgaris

Clascoterone stability when combined with topical acne medications (AAD 2025) - " Tretinoin cream 0.025%, adapalene gel 0.3%, dapsone gel 7.5%, azelaic acid 15%, BP 5%/clindamycin 1%, BP 2.5%/adapalene 0.1%, and encapsulated BP 5% (0.5 mL each) were placed on individual microscope slides with 0.5 mL of clascoterone cream 1% and incubated for 8 hours at 37°C. Clascoterone demonstrated consistent and reproducible stability in the presence of other topical acne medications."

Acne Vulgaris • Dermatology

Reduction in facial sebum production following treatment with clascoterone cream 1% in patients with acne vulgaris: 12-week interim analysis (AAD 2025) - "Clascoterone cream 1% led to significant reductions in sebum measurements with improvements in acne severity, and there were no tolerability or safety issues."

Clinical • Acne Vulgaris • Dermatology

A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients (clinicaltrials.gov) - P4 | N=10 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology

Cosmo and Glenmark Announces UK MHRA Approval of Winlevi for Treatment of Acne (Cosmo Press Release) - "Cosmo Pharmaceuticals N.V...announced that Glenmark had received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Winlevi in the United Kingdom. Winlevi is a topical treatment for acne vulgaris in patients aged 12 years and older, marking a significant milestone in the commitment of both companies to providing innovative, patient-focused dermatology solutions....Two identical phase III studies demonstrated that clascoterone cream 1%, applied topically twice daily for 12 weeks, was more effective than the application of vehicle cream in achieving the Investigator’s Global Assessment (IGA) of success, reducing non-inflammatory lesion count (NILC) and inflammatory lesion count (ILC) in patients with facial acne vulgaris. clascoterone cream 1%, was generally well tolerated."

MHRA approval • Acne Vulgaris • Dermatology

Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Not yet recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

Real-World Experience of Clascoterone Cream 1% in Acne Management: Case Series and Canadian Experience. (PubMed, Clin Cosmet Investig Dermatol) - "Moreover, clascoterone also helped to address other concerns in several patients, including hirsutism, hidradenitis suppurativa, retinoid-induced dermatitis, androgenetic alopecia, folliculitis, postinflammatory hyperpigmentation, and laser-induced acne flares. This early real-world clinical experience supports the effectiveness, tolerability, and versatility of clascoterone cream 1% for patients with acne across a variety of clinical and demographic characteristics."

Journal • Real-world evidence • Acne Vulgaris • Alopecia • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology

Topical Anti-Androgens in Pilonidal Sinus Disease (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: University of Pennsylvania | Not yet recruiting ➔ Recruiting | Trial primary completion date: Aug 2027 ➔ Jan 2028

Enrollment open • Trial primary completion date • Otorhinolaryngology

Prospective Pilot Evaluation of the Safety, Tolerability, and Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel plus Clascoterone 1% Cream in Adult Patients with Acne. (PubMed, J Clin Aesthet Dermatol) - "This pilot evaluation, albeit small and open-label, demonstrates promising results for the first studied combination of topical agents to target all four aspects of acne pathophysiology. Further large-scale studies are needed to further elucidate the additive efficacy and side effect profile when these two topical medications are used concomitantly."

Journal • Acne Vulgaris • Dermatology • Inflammation

Innovations in Acne. (PubMed, Dermatol Clin) - "The mechanisms of action, pivotal trial data, and potential role in clinical practice are reviewed for emerging therapies such as 1726 nm laser, sarecycline, clascoterone, trifarotene, minocycline foam, and fixed-dose combination topicals. The clinical pipeline is also summarized. In addition, opportunities to improve the patient experience with spironolactone and isotretinoin are discussed."

Journal • Review • Acne Vulgaris • Dermatology

Clascoterone for acne. (PubMed, Aust Prescr) - No abstract available

Journal • Review • Acne Vulgaris • Dermatology

Topical, light-based, and complementary interventions for acne: an overview of systematic reviews. (PubMed, Cochrane Database Syst Rev) - "This overview summarises the evidence for topical therapy, phototherapy, and complementary therapy for acne and acne scars. We found no high-certainty evidence for the effects of any therapy included. Randomised controlled trials and systematic reviews related to acne and acne scars had limitations (low methodological quality). We could not summarise the evidence for topical retinoids and topical antibiotics due to insufficient high-quality systematic reviews. Future research should consider pooled analysis of data on new emerging drugs for acne treatment (e.g. clascoterone) and focus more on acne complications."

Clinical • Journal • Review • Acne Vulgaris • Dermatology

A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients (clinicaltrials.gov) - P4 | N=10 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology

Topical Anti-Androgens in Pilonidal Sinus Disease (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: University of Pennsylvania | Initiation date: Aug 2024 ➔ Nov 2024

Trial initiation date • Otorhinolaryngology

A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne (clinicaltrials.gov) - P4 | N=10 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

An update on the pharmacological management of acne vulgaris: the state of the art. (PubMed, Expert Opin Pharmacother) - "Topical therapies such as topical retinoids, benzoyl peroxide, azelaic acid, salicylic acid, topical antibiotics and clascoterone, as well as systemic treatments such as oral antibiotics and isotretinoin are discussed in detail. Combined oral contraceptives and spironolactone will not be discussed in this article. There is a need for a blockbuster acne drug that simultaneously targets the 4 main pathogenic factors involved in the appearance of acne lesions while presenting with minimal side effects. Until such a drug exists, combination therapy will remain the standard of treatment for most acne patients."

Journal • Review • Acne Vulgaris • Dermatology • Inflammation

Efficacy and Safety of Oral Isotretinoin Monotherapy versus In Combination with Topical Clascoterone 1% Cream for Patients with Nodular Acne: A Comparative Retrospective Study (EADV 2024) - "Combination of oral isotretinoin and topical clascoterone 1% demonstrates superior efficacy in reducing acne lesions and achieving IGA success compared to oral isotretinoin monotherapy in patients aged 12 and above with nodular acne. Further investigation with larger sample sizes and extended follow-up periods is warranted to confirm these findings and ascertain the long-term safety and efficacy profiles of combination therapy."

Combination therapy • Monotherapy • Retrospective data • Acne Vulgaris • CNS Disorders • Dermatitis • Immunology

SCALP1: A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (clinicaltrials.gov) - P3 | N=726 | Recruiting | Sponsor: Cassiopea SpA | Trial completion date: Jan 2025 ➔ Apr 2025 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Trial completion date • Trial primary completion date • Alopecia • Dermatology • Immunology

Evaluation of in vitro Skin Permeation of Clascoterone From Clascoterone Topical Cream, 1% (w/w). (PubMed, AAPS PharmSciTech) - "Conversely, degradation of clascoterone was significantly minimized when using the flow-through diffusion cells with fractional sampling. The data enhanced our understanding of in vitro permeation of clascoterone following topical application of the Winlevi topical cream, 1% and underscores the importance of IVPT method development and optimization during product development."

Journal • Preclinical • Acne Vulgaris • Dermatology

Adult Female Acne: Managing the Hormones. (PubMed, Skin Therapy Lett) - "In females, we have the unique opportunity to manipulate hormones systemically to successfully manage acne and, more recently with the approval of clascoterone 1% cream, we can target the hormones topically in both genders. The intent of this paper is to provide physicians with an up-to-date clinically relevant review of the role of hormones in acne, the impact of currently available contraceptives and therapies available to target hormones in acne."

Journal • Review • Acne Vulgaris

Topical Anti-Androgens in Pilonidal Sinus Disease (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: University of Pennsylvania | Initiation date: May 2024 ➔ Aug 2024 | Trial primary completion date: May 2027 ➔ Aug 2027

Trial initiation date • Trial primary completion date • Otorhinolaryngology

Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris (clinicaltrials.gov) - P3 | N=692 | Recruiting | Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Acne Vulgaris • Dermatology