Not Yet RecruitingPhase 1/2

Comparative Effectiveness of Clindamycin-Retinoid, Clindamycin-Retinoid-Dexamethasone, and 10% SM-hUCMSC Secretome Gel in the Improvement of Mild-to-Moderate Acne Vulgaris

Indonesia189 participantsStarted 2026-04-18

Plain-language summary

The goal of this clinical trial is to etermine and compare the effectiveness of three therapeutic regimens for mild to moderate acne vulgaris, such as, clindamycin-retinoid combination, clindamycin-retinoid-dexamethasone combination, and sekretome SM-hUCMSC 10% gel. The main questions it aims to answer are : * Is there a change in the number of inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones) before and after treatment in each treatment group? * Is there a difference in the reduction of acne vulgaris severity scores among the three treatment groups? * Are there differences in the rate of clinical improvement (time required to achieve a certain reduction in lesion count or severity score) among the treatment groups? * What are the incidence and characteristics of local adverse effects (erythema, burning sensation, skin dryness, irritation, hypo-/hyperpigmentation, and others) in each treatment group? * Are there differences in the impact of each therapeutic regimen on the risk of acne scar formation and improvement in skin quality (texture, elasticity, and color homogeneity)? * Does secretome gel demonstrate sufficient clinical potential and urgency as a safer and more prospective topical therapeutic alternative for acne vulgaris compared with retinol-clindamycin and retinol-clindamycin-dexamethasone 0.1% combinations? Participants will be allocated into three groups using simple block randomization. * Group A will receive a combination of clindamycin and a retinoid, applied thinly to the entire facial area once daily at night. * Group B will receive a combination of clindamycin, a retinoid, and dexamethasone, with the same method of application as Group A. * Group C will receive 10% SM-hUCMSC secretome gel, applied thinly to acne-affected areas twice daily (morning and night).

Who can participate

Age range15 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 15-40 years. * Clinical diagnosis of mild to moderate acne vulgaris on the facial area. * Primary lesion location on the face, with a total lesion count meeting the above criteria. * Not currently using topical or systemic acne therapy within: the past 2 weeks for topical therapy; the past 4 weeks for systemic therapy (oral antibiotics, isotretinoin, or systemic steroids). * Willing to use only the treatment regimen provided by the investigators on the facial area throughout the study period. * Willing to adhere to the scheduled follow-up visits (weeks 0, 2, 4, and 8) and to sign informed consent. Exclusion Criteria: * Presence of other facial skin diseases that may interfere with acne assessment (e.g., rosacea, contact dermatitis, impetigo, fungal infections, herpes, etc.). * History of hypersensitivity or allergy to clindamycin, retinoids, topical corticosteroids, or any components of the secretome gel. * Use of oral isotretinoin within the past 6 months. * Pregnancy or breastfeeding. * History of severe immunological disorders or uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, severe liver or kidney disease). * Presence of extensive open wounds or active infections on the face. * Undergoing aggressive facial cosmetic procedures within the past 3 months (e.g., ablative laser, deep chemical peeling, dermabrasion).

What they're measuring

Percentage reduction in total acne lesions (inflammatory and non-inflammatory) from baseline to week 8.

Timeframe: 8 weeks

Change in acne severity grade (ISGA) between baseline and week 8.

Timeframe: week 8

Trial details

NCT IDNCT07504822

SponsorYohanes Firmansyah, dr, MH, MM

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-18

Contact for this trial

Yohanes Firmansyah, M.H., M.M., M.Biomed., M.K.M.,

+6281297934375 yohanes@fk.untar.ac.id