Skin AgingPhase 2NCT07477288
Effectiveness of a Bilayering Serum and Cream Containing GABA, DMAE, Cysteamine, and Bakuchiol for Skin Whitening and Anti-Aging
A Phase 2 study testing GABA, DMAE and Cysteamine in people with Skin Aging, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- GABA, DMAE and Cysteamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Mar 2025to 29 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females aged 30-50 years.
Who cannot join
- History of hypersensitivity to GABA, DMAE, Cysteamine, or Bakuchiol.
- Recent facial aesthetic procedures (e.g., laser, chemical peel) within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Hasanuddin University
Makassar, South Sulawesi, 90245
About this study
Official 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%
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
- Being tested
- GABA, Placebo, DMAE, Cysteamine, Bakuchiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GABADrug
Gamma-Aminobutyric Acid (GABA) 3%
PlaceboOther
Formulations with identical sensory properties (color, scent, and texture) as the active products but lacking the four active ingredients.
DMAEDrug
Dimethylaminoethanol 2%
CysteamineDrug
Cysteamine 2,5%
BakuchiolDrug
Bakuchiol 1%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: (Day 0) and Week 8 (Day 56).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start12 Mar 2025
- Primary completion26 Sep 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Widya Widita, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477288
- Sponsor's protocol ID
- 93/UN4.6.4.5.3L / PP36,/ 2025
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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%
- ClinicalTrials.gov ID
- NCT07477288
- Acronym / sponsor ID
- 93/UN4.6.4.5.3L / PP36,/ 2025
- Conditions
- Skin Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilayering Treatment Group | Experimental | Drug: GABA, Drug: DMAE, Drug: Cysteamine, Drug: BakuchiolParticipants 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. |
| Placebo Control Group | Placebo comparator | Other: PlaceboParticipants 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 |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy females aged 30-50 years.
Key exclusion criteria (2 listed)
- History of hypersensitivity to GABA, DMAE, Cysteamine, or Bakuchiol.
- Recent facial aesthetic procedures (e.g., laser, chemical peel) within the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GABAGamma-Aminobutyric Acid (GABA) 3% | Drug | Bilayering Treatment Group |
| PlaceboFormulations with identical sensory properties (color, scent, and texture) as the active products but lacking the four active ingredients. | Other | Placebo Control Group |
| DMAEDimethylaminoethanol 2% | Drug | Bilayering Treatment Group |
| CysteamineCysteamine 2,5% | Drug | Bilayering Treatment Group |
| BakuchiolBakuchiol 1% | Drug | Bilayering Treatment Group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for Skin Aging
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GABA, DMAE and Cysteamine in people with Skin Aging, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Luminance (L*) as measured by Chromameter. (time frame: Baseline (Day 0) and Week 8 (Day 56).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.