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

March 28, 2026 updated by: Yohanes Firmansyah, dr, MH, MM

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine and compare the effectiveness of three therapeutic regimens for mild to moderate acne vulgaris: (1) a combination of clindamycin-retinoid, (2) a combination of clindamycin-retinoid-dexamethasone, and (3) 10% SM-hUCMSC secretome gel.

This study employed a quasi-experimental pre-post design with three intervention arms and was conducted at the Precious Me Clinic, Serpong. Subjects were divided into three groups:

Group A received Mediklin TR (clindamycin-retinoid), applied once daily at night.

Group B received Solanum Night Cream (clindamycin-retinoid-dexamethasone), applied once daily at night.

Group C received 10% SM-hUCMSC secretome gel. The secretome was derived from human umbilical cord mesenchymal stem cells (SM-hUCMSC) cultured up to passage 6 in MEM-α medium without growth supplements, incubated under hypoxic conditions (5% O₂) for 72 hours, and the conditioned medium was stored at -80°C before being formulated into a 10% gel. The gel was applied thinly to acne-affected areas twice daily (morning and night) for 8 weeks. Evaluations were performed at weeks 0, 2, 4, and 8.

Throughout the trial period, participants were instructed to continue using sunscreen and were allowed to use the same mild facial cleanser and non-comedogenic moisturizer (standardized by the investigators) to minimize bias.

The study utilized an AI-assisted face/skin analyzer (e.g., Langdi Skin Analyzer), acne lesion count forms, the Cardiff Acne Disability Index (CADI) questionnaire, adverse event recording sheets, and a standard digital camera as research instruments.

Study Type

Interventional

Enrollment (Estimated)

189

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yohanes Firmansyah, M.H., M.M., M.Biomed., M.K.M.,
  • Phone Number: +6281297934375
  • Email: yohanes@fk.untar.ac.id

Study Locations

  • Indonesia
      • Tangerang, Indonesia
        • Klinik Precious Me

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Use Mediklin TR
Combination product: Mediklin TR
-Mediklin TR (Clindamisin + Retinoid)
Experimental: B
Group B received Solanum Night Cream
Combination product: Solanum Night Cream
Solanum Night Cream (Clindamisin + Retinoid + Dexamethasone)
Experimental: C
Group C received 10% SM-hUCMSC secretome gel.
Combination product: Gel Sekretome SM-hUCMSC 10%
The secretome was derived from human umbilical cord mesenchymal stem cells (SM-hUCMSC) cultured up to passage 6 in MEM-α medium without growth supplements, incubated under hypoxic conditions (5% O₂) for 72 hours, and the conditioned medium was stored at -80°C before being formulated into a 10% gel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage reduction in total acne lesions (inflammatory and non-inflammatory) from baseline to week 8.
Time Frame: 8 weeks
Percentage reduction in inflammatory and non-inflammatory lesions analyzed separately.
8 weeks
Change in acne severity grade (ISGA) between baseline and week 8.
Time Frame: week 8

Changes in AI-based Face/Skin Analyzer parameters (Spot, Pore, Wrinkle, UV Moisture, UV Damage, Roughness, Porphyrin, Pigmentation, and Hydration) from baseline to weeks 4 and 8, with reference to previous combination cream and secretome studies.

Change in CADI scores from baseline to week 8.
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yohanes Firmansyah, dr, MH, MM

Collaborators

Universitas Tarumanagara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 18, 2026

Primary Completion (Estimated)

March 18, 2027

Study Completion (Estimated)

January 18, 2028

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15.01.2026.13.53

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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