Skin Aging
Conditions
Brief summary
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.
Interventions
DRUGGABA
Gamma-Aminobutyric Acid (GABA) 3%
OTHERPlacebo
Formulations with identical sensory properties (color, scent, and texture) as the active products but lacking the four active ingredients.
DRUGDMAE
Dimethylaminoethanol 2%
DRUGCysteamine
Cysteamine 2,5%
DRUGBakuchiol
Bakuchiol 1%
Sponsors
Hasanuddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy females aged 30-50 years.
Exclusion criteria
* History of hypersensitivity to GABA, DMAE, Cysteamine, or Bakuchiol. * Recent facial aesthetic procedures (e.g., laser, chemical peel) within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Luminance (L*) as measured by Chromameter. | Baseline (Day 0) and Week 8 (Day 56). | 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 |
| Percentage change in skin wrinkles as assessed by Skin Analyzer. | (Day 0) and Week 8 (Day 56). | 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. |
Countries
Indonesia
Outcome results
None listed