Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

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:

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Participants will used the serum twice daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effect after using the serum.	Based on adverse effect occurrence on participants that occur during study period (8 weeks)	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Week 8

Collaborators and Investigators

• Sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cosmetic; Aesthetic; Post-inflammatory hyperpigmentation (PIH)
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Skin and Connective Tissue Diseases; Hyperpigmentation; Organic Chemicals; Fatty Acids; Lipids; Biological Factors; Carboxylic Acids; Hydroxy Acids; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Lactates; Lactic Acid; glycolic acid; Prostaglandins A
• Other Study ID Numbers: UMRAMREC001-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No