Comparative Effectiveness of Clindamycin-Retinoid, Clindamycin-Retinoid-Dexamethasone, and 10% SM… (NCT07504822) | Clinical Trial Compass
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 range
15 Years – 40 Years
Sex
ALL
See this in plain English?
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage reduction in total acne lesions (inflammatory and non-inflammatory) from baseline to week 8.
Timeframe: 8 weeks
2
Change in acne severity grade (ISGA) between baseline and week 8.