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

COMPLETEDPHASE4

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

Clinical Evaluation of the Sebum Reduction Induced by Clascoterone Cream 1%

NCT06415279•Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

Summary

The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes. If no sebum is present, there is no nutritional source for the c. acnes, the bacteria die, and acne resolves. A newly FDA approved acne medication consisting of clascoterone cream 1% is believed to effectively treat acne due to a decrease in sebum production. This mechanism of action has been postulated based on efficacy observed in the phase III trials that lead to its approval. This research aims to demonstrate the effect of clascoterone cream 1% in sebum reduction.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females 12+ years of age.
•2. Subjects with mild to moderate acne.
•3. Subjects must possess 10-100 total non-inflammatory lesions (open comedones and closed comedones), 10-50 total inflammatory lesions, no cysts, and up to 2 nodules (if deemed appropriate by the PI) on the face.
•4. Subjects with all Fitzpatrick skin types I-VI.
•5. Subjects who agree to use only the study products for acne treatment. No other medicated cleansers or moisturizers or acne treatments of any kind are allowed.
•6. Subjects agree not to introduce any new colored cosmetics or skin care products while participating in the study (lipsticks, eye shadows, facial foundations, blush, powder, cleansers, moisturizers).
•7. Subjects agree to arrive at all visits with a clean face, having washed his/her face and removed all facial and eye makeup products within 2 hours to 4 hours prior to the visit and is not to use/apply any topical facial product(s) until the visit is completed.
•8. No known medical conditions that, in the investigator's opinion, may interfere with study participation.
•9. Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence.
•10. Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
+5 more criteria

Exclusion Criteria

•1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne.
•2. Subjects who are not willing to use the assigned study product to their face as instructed.
•3. Subjects who have acne nodules/cysts representative of severe acne.
•4. Subjects who are currently using, planning to use during the study or has used any of the following in the specified time range (based on subject report):
•* 1 month prior to Visit 1: Prescription (oral or topically applied on the face) antibiotics, inhaled steroids (except those prescribed for allergies), or hormones (pre- or post-menopausal hormone-replacement therapy; insulin, etc.), or other medications that could make skin more sensitive or have an effect on the skin, as determined by the PI or designee. Oral contraceptives are acceptable.
•* 1 month prior to Visit 1: Prescription medication for acne (e.g. doxycycline, minocycline, clindamycin, sulfamethoxazole and trimethoprim \[Bactrim\], tetracycline, erythromycin, azithromycin, or Vibramycin®)
•* 1 month prior to Visit 1: Topical prescription retinoids (e.g. Retin-A®, Retin-A Micro®, Renova®, Adapalene, Tazarotene, Avita®, Tazorac®, Avage®, Differin®), azelaic acid, benzoyl peroxide, dapsone, sodium sulfacetamide, Epiduo®, or other similar prescription drug on the face
•* 6 months prior to Visit 1: Accutane or other oral retinoid
•* 2 weeks prior to Visit 1: Any of the following on the face:
•* Light therapy
+16 more criteria

Locations (1)

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States

Key Dates

Start Date

February 29, 2024

Primary Completion Date

February 18, 2025

Completion Date

February 18, 2025

Last Updated

April 15, 2025

Enrollment

ACTUAL participants

Conditions

Acne Vulgaris

Interventions

Winlevi (clascoterone) 1% cream

DRUG

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

NCT07205107

Acne Vulgaris

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RECRUITINGPHASE1/PHASE2

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

NCT05891795

Acne Vulgaris

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RECRUITINGNA

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

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

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris

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