- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477288
Effectiveness of a Bilayering Serum and Cream Containing GABA, DMAE, Cysteamine, and Bakuchiol for Skin Whitening and Anti-Aging
March 20, 2026 updated by: Widya Widita, Hasanuddin University
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%
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Sulawesi
-
Makassar, South Sulawesi, Indonesia, 90245
- Faculty of Medicine, Hasanuddin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bilayering Treatment Group
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.
|
Gamma-Aminobutyric Acid (GABA) 3%
Dimethylaminoethanol 2%
Cysteamine 2,5%
Bakuchiol 1%
|
|
Placebo Comparator: Placebo Control Group
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
|
Formulations with identical sensory properties (color, scent, and texture) as the active products but lacking the four active ingredients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline (Day 0) and Week 8 (Day 56).
|
|
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.
|
(Day 0) and Week 8 (Day 56).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2025
Primary Completion (Actual)
September 26, 2025
Study Completion (Actual)
December 29, 2025
Study Registration Dates
First Submitted
March 7, 2026
First Submitted That Met QC Criteria
March 12, 2026
First Posted (Actual)
March 17, 2026
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 93/UN4.6.4.5.3L / PP36,/ 2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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