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OpenTrials
Completed

NCT Number: NCT07477288

Effectiveness of a Bilayering Serum and Cream Containing GABA, DMAE, Cysteamine, and Bakuchiol for Skin Whitening and Anti-Aging

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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Key information

Conditions

Skin Aging

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GABA

Drug

Gamma-Aminobutyric Acid (GABA) 3%

Placebo

Other

Formulations with identical sensory properties (color, scent, and texture) as the active products but lacking the four active ingredients.

DMAE

Drug

Dimethylaminoethanol 2%

Cysteamine

Drug

Cysteamine 2,5%

Bakuchiol

Drug

Bakuchiol 1%

Primary outcomes

  1. Change in Skin Luminance (L*) as measured by Chromameter.

    Time frame: 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

  2. Percentage change in skin wrinkles as assessed by Skin Analyzer.

    Time frame: (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.

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Official study title

The Effectiveness of a Whitening and Anti-Aging Bilayering Serum and Cream Containing Gamma-Aminobutyric Acid (GABA) 3%, Dimethylaminoethanol (DMAE) 2%, Cysteamine 2.5%, and Bakuchiol 1%

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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