NCT05998200

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2023

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

August 1, 2023

Last Update Submit

March 4, 2026

Conditions

Healthy

Keywords

AestheticCosmeticPost-inflammatory hyperpigmentation (PIH)

Outcome Measures

Primary Outcomes (1)

  • Adverse effect after using the serum.

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

    Week 8

Secondary Outcomes (5)

  • Change in skin moisture level

    Baseline, Week 4 and Week 8

  • Change in skin spot level

    Baseline, Week 4 and Week 8

  • Change in skin pores level

    Baseline, Week 4 and Week 8

  • Change in skin tone level

    Baseline, Week 4 and Week 8

  • Participant satisfaction after using the serum for 8 week.

    Week 8

Study Arms (1)

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.

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

Interventions

Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGAOTHER

Participants will used the serum twice daily for 8 weeks

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

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Petaling Jaya, Selangor, 47810, Malaysia

Location

MeSH Terms

Conditions

Hyperpigmentation

Interventions

glycolic acidLactic AcidProstaglandins A

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic ChemicalsProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 18, 2023

Study Start

July 1, 2023

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)