Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin
Study Details
Study Description
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:
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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.
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To assess the patient satisfaction after using serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA among Malaysian.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Adverse effect after using the serum. [Week 8]
Based on adverse effect occurrence on participants that occur during study period (8 weeks)
Secondary Outcome Measures
- Change in skin moisture level [Baseline, Week 4 and Week 8]
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.
- Change in skin spot level [Baseline, Week 4 and Week 8]
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.
- Change in skin pores level [Baseline, Week 4 and Week 8]
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.
- Change in skin tone level [Baseline, Week 4 and Week 8]
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.
- Participant satisfaction after using the serum for 8 week. [Week 8]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Malaysian from 18 to 40 years old.
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Participants with post-inflammatory hyperpigmentation (PIH).
Exclusion Criteria:
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Participant with known systemic or skin disease and any underlying medical illness
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Pregnant, breastfeeding women or planned pregnancy during the study period.
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Had reported history of dermatologic conditions (i.e. Atopic dermatitis, psoriasis) or known allergies to any ingredients that may be found in the product.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre | Petaling Jaya | Selangor | Malaysia | 47810 |
Sponsors and Collaborators
- Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UMRAMREC001-23