NCT07504822

Brief 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).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_1

Timeline
17mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Apr 2026Jan 2028

First Submitted

Initial submission to the registry

March 13, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

April 18, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 13, 2026

Last Update Submit

March 28, 2026

Conditions

Acne Vulgaris

Keywords

Acne vulgarisClindamycinDexamethasoneRetinoidSecretome

Outcome Measures

Primary Outcomes (2)

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

    Percentage reduction in inflammatory and non-inflammatory lesions analyzed separately.

    8 weeks

  • Change in acne severity grade (ISGA) between baseline and 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

Study Arms (3)

A

EXPERIMENTAL

Use Mediklin TR

Combination Product: Mediklin TR

B

EXPERIMENTAL

Group B received Solanum Night Cream

Combination Product: Solanum Night Cream

C

EXPERIMENTAL

Group C received 10% SM-hUCMSC secretome gel.

Combination Product: Gel Sekretome SM-hUCMSC 10%

Interventions

Mediklin TRCOMBINATION_PRODUCT

-Mediklin TR (Clindamisin + Retinoid)

A
Solanum Night CreamCOMBINATION_PRODUCT

Solanum Night Cream (Clindamisin + Retinoid + Dexamethasone)

B
Gel Sekretome SM-hUCMSC 10%COMBINATION_PRODUCT

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.

C

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Precious Me

Tangerang, Indonesia

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Central Study Contacts

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

CONTACT

+6281297934375yohanes@fk.untar.ac.id

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Officer

Study Record Dates

First Submitted

March 13, 2026

First Posted

April 1, 2026

Study Start

April 18, 2026

Primary Completion (Estimated)

March 18, 2027

Study Completion (Estimated)

January 18, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

ID(1)