NCT05998200CompletedNot Applicable
Safety of Serum Containing Alpha Hydroxy Acid (AHA) and Polyglutamate Acid Derivatives for Post-Inflammatory on Hyperpigmentation Skin
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre1 site in 1 country34 target enrollmentStarted: July 1, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Adverse effect after using the serum.
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
Other
This serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA.
Intervention: Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA (Other)
Outcomes
Primary Outcomes
Adverse effect after using the serum.
Time Frame: Week 8
Based on adverse effect occurrence on participants that occur during study period (8 weeks)
Secondary Outcomes
- Change in skin pores level(Baseline, Week 4 and Week 8)
- Change in skin tone level(Baseline, Week 4 and Week 8)
- Change in skin moisture level(Baseline, Week 4 and Week 8)
- Change in skin spot level(Baseline, Week 4 and Week 8)
- Participant satisfaction after using the serum for 8 week.(Week 8)
Investigators
Study Sites (1)
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