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CompletedNCT05998200Updated Mar 6, 2026

Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

An interventional study of Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA in Healthy, sponsored by USMARI Research & Innovation Centre. Completed at 1 site in Malaysia. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by USMARI Research & Innovation Centre · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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. 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:

  1. 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.
  2. To assess the patient satisfaction after using serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA among Malaysian.
02

Conditions studied

  • Healthy

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Keywords

  • Aesthetic
  • Cosmetic
  • Post-inflammatory hyperpigmentation (PIH)
03

In context

Hyperpigmentation

127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.

This study's enrollment of 34 is close to the median of 32 across 113 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

USMARI Research & Innovation Centre is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Malaysian from 18 to 40 years old.
  • Participants with post-inflammatory hyperpigmentation (PIH).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Other
    Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA

    This serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA.

    Other: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA

Interventions

  • OtherSerum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA

    Participants will used the serum twice daily for 8 weeks

06

What researchers measure

Primary outcomes

  1. Adverse effect after using the serum.

    Based on adverse effect occurrence on participants that occur during study period (8 weeks)

    Time frame: Week 8

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week 4 and Week 8

  2. 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.

    Time frame: Baseline, Week 4 and Week 8

  3. 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.

    Time frame: Baseline, Week 4 and Week 8

  4. 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.

    Time frame: Baseline, Week 4 and Week 8

  5. 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.

    Time frame: Week 8

07

Study locations

1 site
  • Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
    Petaling Jaya, Selangor 47810, Malaysia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05998200
Lead sponsor
USMARI Research & Innovation Centre
Responsible party
Sponsor
First posted
Aug 18, 2023
Start date
Jul 1, 2023
Primary completion
Oct 30, 2025
Completion
Oct 30, 2025
Last update
Mar 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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