Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

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

Official Title
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Safety of Serum Containing Alpha Hydroxy Acid (AHA) and Polyglutamate Acid Derivatives for Post-Inflammatory on Hyperpigmentation Skin

Conditions
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Healthy

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA<br>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<br>* Participants will used the serum twice daily for 8 weeks<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aesthetic, Cosmetic, Post-inflammatory hyperpigmentation (PIH)