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

NCT07477288 | Completed Phase 2

• 1 other identifier: 93/UN4.6.4.5.3L / PP36,/ 2025
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (2)

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.

Drug: GABA; Drug: DMAE; Drug: Cysteamine; Drug: Bakuchiol

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

Other: Placebo

Interventions

GABA DRUG

Gamma-Aminobutyric Acid (GABA) 3%

Bilayering Treatment Group

Placebo OTHER

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

Placebo Control Group

DMAE DRUG

Dimethylaminoethanol 2%

Bilayering Treatment Group

Cysteamine DRUG

Cysteamine 2,5%

Bilayering Treatment Group

Bakuchiol DRUG

Bakuchiol 1%

Bilayering Treatment Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy females aged 30-50 years.

You may not qualify if:

• History of hypersensitivity to GABA, DMAE, Cysteamine, or Bakuchiol.
• Recent facial aesthetic procedures (e.g., laser, chemical peel) within the last 3 months.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Faculty of Medicine, Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Interventions

gamma-Aminobutyric Acid; Cysteamine; bakuchiol

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Mercaptoethylamines; Ethylamines; Amines; Sulfhydryl Compounds; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Dermatologist

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 17, 2026
• Study Start: March 12, 2025
• Primary Completion: September 26, 2025
• Study Completion: December 29, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

ID (1)