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This study aims to evaluate the clinical efficacy and safety of a multi-functional bilayering skincare regimen-consisting of a serum and cream-for improving skin brightness and reducing wrinkles. The formulation combines four active ingredients: Gamma-Aminobutyric Acid (GABA) 3%, Dimethylaminoethanol (DMAE) 2%, Cysteamine 2.5%, and Bakuchiol 1%. In an 8-week, double-blind, randomized, placebo-controlled trial involving 44 female subjects with Fitzpatrick skin types III-V, investigators will assess changes in skin brightness (L-value), wrinkle scores, pore counts, and melanin/erythema indices using standardized imaging and measurement tools. The primary goal is to determine if this specific combination therapy significantly enhances skin whitening and anti-aging outcomes compared to a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilayering Treatment Group | Experimental | Participants apply a serum of GABA 3% and DMAE 2% followed by a cream containing Cysteamine 2.5% and Bakuchiol 1% to the face twice daily for 8 weeks. to the face twice daily for 8 weeks. |
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| Placebo Control Group | Placebo Comparator | Participants apply a placebo serum and cream, identical in appearance, fragrance, and texture to the active products but without the active ingredients (GABA, DMAE, Cysteamine, and Bakuchiol), twice daily for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GABA | Drug | Gamma-Aminobutyric Acid (GABA) 3% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Luminance (L*) as measured by Chromameter. | Skin color is assessed using the CIE Lab* system. The L* parameter specifically measures luminance/brightness on a scale of 0 (black) to 100 (white). An increase in L* value indicates an improvement in skin lightness | Baseline (Day 0) and Week 8 (Day 56). |
| Percentage change in skin wrinkles as assessed by Skin Analyzer. | The Skin Analyzer evaluates the depth and area of facial wrinkles through digital imaging, providing a percentage value of the analyzed area. A lower percentage indicates a reduction in wrinkle appearance. | (Day 0) and Week 8 (Day 56). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Hasanuddin University | Makassar | South Sulawesi | 90245 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2025 | Mar 7, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D003543 | Cysteamine |
| C012765 | bakuchiol |
| ID | Term |
|---|---|
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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The active products and placebo were provided in identical packaging, labeled with unique codes. Neither the participants nor the investigators knew which group received the active bilayering formulation until the completion of the 8-week study and data analysis
| Placebo |
| Other |
Formulations with identical sensory properties (color, scent, and texture) as the active products but lacking the four active ingredients. |
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| DMAE | Drug | Dimethylaminoethanol 2% |
|
| Cysteamine | Drug | Cysteamine 2,5% |
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| Bakuchiol | Drug | Bakuchiol 1% |
|
| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008624 | Mercaptoethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |