Acne VulgarisPhase 1/2Acne VulgarisNCT07504822
Comparative Effectiveness of Clindamycin-Retinoid, Clindamycin-Retinoid-Dexamethasone, and 10% SM-hUCMSC Secretome Gel in the Improvement of Mild-to-Moderate Acne Vulgaris
A Phase 1/2 study testing Mediklin TR, Solanum Night Cream and Gel Sekretome SM-hUCMSC 10% in people with Acne Vulgaris, run by Yohanes Firmansyah, dr, MH, MM at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Mediklin TR, Solanum Night Cream and Gel Sekretome SM-hUCMSC 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Apr 2026to 18 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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).
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Mediklin TR, Solanum Night Cream, Gel Sekretome SM-hUCMSC 10%
- Keywords
- Acne vulgaris, Clindamycin, Dexamethasone, Retinoid, Secretome
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediklin TRCombination product
-Mediklin TR (Clindamisin + Retinoid)
Solanum Night CreamCombination product
Solanum Night Cream (Clindamisin + Retinoid + Dexamethasone)
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Use Mediklin TR Receives: Combination Product: Mediklin TR |
| B | Experimental | Group B received Solanum Night Cream Receives: Combination Product: Solanum Night Cream |
| C | Experimental | Group C received 10% SM-hUCMSC secretome gel. Receives: Combination Product: Gel Sekretome SM-hUCMSC 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start18 Apr 2026 (estimated)
- Primary completion18 Mar 2027 (estimated)
- Study completion18 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yohanes Firmansyah, dr, MH, MM
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Tarumanagara
- Responsible party
- Sponsor-investigator, Yohanes Firmansyah, dr, MH, MM, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504822
- Sponsor's protocol ID
- 15.01.2026.13.53
- Acronym
- Acne Vulgaris
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07504822
- Acronym / sponsor ID
- Acne Vulgaris / 15.01.2026.13.53
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, Clindamycin, Dexamethasone, Retinoid, Secretome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Yohanes Firmansyah, dr, MH, MMUniversity, hospital or other
- Collaborators
- Universitas Tarumanagara
- Study start
- 18 Apr 2026 (estimated)
- Primary completion
- 18 Mar 2027 (estimated)
- Study completion
- 18 Jan 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Combination Product: Mediklin TRUse Mediklin TR |
| B | Experimental | Combination Product: Solanum Night CreamGroup B received Solanum Night Cream |
| C | Experimental | Combination Product: Gel Sekretome SM-hUCMSC 10%Group C received 10% SM-hUCMSC secretome gel. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediklin TR-Mediklin TR (Clindamisin + Retinoid) | Combination product | A |
| Solanum Night CreamSolanum Night Cream (Clindamisin + Retinoid + Dexamethasone) | Combination product | B |
| 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. | Combination product | C |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mediklin TR, Solanum Night Cream and Gel Sekretome SM-hUCMSC 10% in people with Acne Vulgaris, run by Yohanes Firmansyah, dr, MH, MM at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yohanes Firmansyah, M.H., M.M., M.Biomed., M.K.M., (+6281297934375, yohanes@fk.untar.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in total acne lesions (inflammatory and non-inflammatory) from baseline to week 8. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.