HealthyNCT05998200
Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin
A study testing Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA in people with Healthy, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
Trial summary
This study aims to investigate the safety of serum product containing low dose of alpha hydroxy acid (AHA) i.e. 1% Glycolic acid and Lactic acid and Polyglutamate acid derivatives (PGA) for post-inflammatory hyperpigmentation skin in Malaysia. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2023to 30 Oct 2025
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysian from 18 to 40 years old.
- Participants with post-inflammatory hyperpigmentation (PIH).
Who cannot join
- Participant with known systemic or skin disease and any underlying medical illness
- Pregnant, breastfeeding women or planned pregnancy during the study period.
- Had reported history of dermatologic conditions (i.e. Atopic dermatitis, psoriasis) or known allergies to any ingredients that may be found in the product.
- Had any cosmetic procedures such as Botox, laser and light treatment, facial surgery, chemical peel and any procedures that may improve skin texture 1 month before the study.
- Had history of taking isotretinoin for the past 6 or 12 month and AHA (alpha hydroxyl acids) containing products or any other products for treating hyperpigmentation skin or melasma 1 month prior to study.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Petaling Jaya, Selangor, 47810
About this study
Official title: Safety of Serum Containing Alpha Hydroxy Acid (AHA) and Polyglutamate Acid Derivatives for Post-Inflammatory on Hyperpigmentation Skin
This study aims to investigate the safety of serum product containing low dose of alpha hydroxy acid (AHA) i.e. 1% Glycolic acid and Lactic acid and Polyglutamate acid derivatives (PGA) for post-inflammatory hyperpigmentation skin in Malaysia. The study duration is 8 weeks and the skin assessment will be carried out at baseline, week 4 and week 8.The main questions this study aims to answer are:
- To investigate the safety of serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA for post-inflammatory hyperpigmentation skin among Malaysian.
- To assess the patient satisfaction after using serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA among Malaysian.
- Conditions
- Healthy
- Being tested
- Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
- Keywords
- Aesthetic, Cosmetic, Post-inflammatory hyperpigmentation (PIH)
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGAOther
Participants will used the serum twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA | Other | This serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA. Receives: Other: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effect after using the serum.
Based on adverse effect occurrence on participants that occur during study period (8 weeks)
Measured: Week 8
Secondary outcomes (5)
Change in skin moisture level
Skin moisture will be measure using JANUS III skin analyzer and the changes in skin moisture from baseline and at week 4 and week 8 will be compared.
Measured: Baseline, Week 4 and Week 8
Change in skin spot level
Skin spot will be measure using JANUS III skin analyzer and the changes in skin spot from baseline and at week 4 and week 8 will be compared.
Measured: Baseline, Week 4 and Week 8
Change in skin pores level
Skin pores will be measure using JANUS III skin analyzer and the changes in skin pores from baseline and at week 4 and week 8 will be compared.
Measured: Baseline, Week 4 and Week 8
Change in skin tone level
Skin tone will be measure using JANUS III skin analyzer and the changes in skin tone from baseline and at week 4 and week 8 will be compared.
Measured: Baseline, Week 4 and Week 8
Participant satisfaction after using the serum for 8 week.
Participation satisfaction will be evaluated using the Physician Global Assessment (PGA) survey. The subjective score of changes in skin conditions including skin wrinkles, dryness, smoothness, moisturizing and brightening effect will be graded as follows: very satisfied, satisfied, neutral, dissatisfied, very dissatisfied.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Jul 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- USMARI Research & Innovation Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998200
- Sponsor's protocol ID
- UMRAMREC001-23
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Serum Containing Alpha Hydroxy Acid (AHA) and Polyglutamate Acid Derivatives for Post-Inflammatory on Hyperpigmentation Skin
- ClinicalTrials.gov ID
- NCT05998200
- Acronym / sponsor ID
- UMRAMREC001-23
- Conditions
- Healthy
- Keywords
- Aesthetic, Cosmetic, Post-inflammatory hyperpigmentation (PIH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- USMARI Research & Innovation CentreIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 18 Aug 2023 (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 investigate the safety of serum product containing low dose of alpha hydroxy acid (AHA) i.e. 1% Glycolic acid and Lactic acid and Polyglutamate acid derivatives (PGA) for post-inflammatory hyperpigmentation skin in Malaysia. The study duration is 8 weeks and the skin assessment will be carried out at baseline, week 4 and week 8.The main questions this study aims to answer are:
- To investigate the safety of serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA for post-inflammatory hyperpigmentation skin among Malaysian.
- To assess the patient satisfaction after using serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA among Malaysian.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA | Other | Other: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGAThis serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Malaysian from 18 to 40 years old.
- Participants with post-inflammatory hyperpigmentation (PIH).
Key exclusion criteria (5 listed)
- Participant with known systemic or skin disease and any underlying medical illness
- Pregnant, breastfeeding women or planned pregnancy during the study period.
- Had reported history of dermatologic conditions (i.e. Atopic dermatitis, psoriasis) or known allergies to any ingredients that may be found in the product.
- Had any cosmetic procedures such as Botox, laser and light treatment, facial surgery, chemical peel and any procedures that may improve skin texture 1 month before the study.
- Had history of taking isotretinoin for the past 6 or 12 month and AHA (alpha hydroxyl acids) containing products or any other products for treating hyperpigmentation skin or melasma 1 month prior to study.
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 |
|---|---|---|
| Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGAParticipants will used the serum twice daily for 8 weeks | Other | Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA |
Primary outcome
Adverse effect after using the serum.
Time frame: Week 8
Based on adverse effect occurrence on participants that occur during study period (8 weeks)
5 secondary outcomes
Change in skin moisture level
Time frame: Baseline, Week 4 and Week 8
Change in skin spot level
Time frame: Baseline, Week 4 and Week 8
Change in skin pores level
Time frame: Baseline, Week 4 and Week 8
Change in skin tone level
Time frame: Baseline, Week 4 and Week 8
Participant satisfaction after using the serum for 8 week.
Time frame: Week 8
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 6 Mar 2026.
- Individual participant dataSharing planned: No
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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 study testing Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA in people with Healthy, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
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 2 inclusion and 5 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 6 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 Malaysia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Adverse effect after using the serum. (time frame: Week 8). 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 6 Mar 2026.