Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

NCT ID: NCT05998200

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

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

Intervention Type OTHER

Participants will used the serum twice daily for 8 weeks

Interventions

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

Participants will used the serum twice daily for 8 weeks

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Petaling Jaya, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Facility Contacts

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SITI NUR HANIS MAMOOD

Role: primary

+60167572670

Nur Izzati Abdul Rashid

Role: backup

+60167252670

Other Identifiers

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UMRAMREC001-23

Identifier Type: -

Identifier Source: org_study_id

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