CompletedPhase 4

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

United States40 participantsStarted 2024-02-29

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Males and females 12+ years of age.
✓. Subjects with mild to moderate acne.
✓. 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.
✓. Subjects with all Fitzpatrick skin types I-VI.
✓. 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.
✓. 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).
✓. 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.
✓. No known medical conditions that, in the investigator's opinion, may interfere with study participation.

Exclusion criteria

What they're measuring

The primary efficacy endpoint is the change in causal sebum measurements from the forehead obtained with a sebumeter during the study.

Timeframe: Weeks 16

Trial details

NCT IDNCT06415279

SponsorSun Pharmaceutical Industries Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-18

View on ClinicalTrials.gov More Acne Vulgaris trials