Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre34 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

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

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

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

Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes