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| Name | Class |
|---|---|
| Universitas Tarumanagara | UNKNOWN |
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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 :
Participants will be allocated into three groups using simple block randomization.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Use Mediklin TR |
|
| B | Experimental | Group B received Solanum Night Cream |
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| C | Experimental | Group C received 10% SM-hUCMSC secretome gel. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediklin TR | Combination Product | -Mediklin TR (Clindamisin + Retinoid) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yohanes Firmansyah, M.H., M.M., M.Biomed., M.K.M., | Contact | +6281297934375 | yohanes@fk.untar.ac.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Precious Me | Tangerang | Indonesia |
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| Solanum Night Cream |
| Combination 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. |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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