Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998200
• Other study ID #: UMRAMREC001-23
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: September 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hyperpigmentation

Intervention

Other:
• Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
Participants will used the serum twice daily for 8 weeks

Locations

Country	Name	City	State
Malaysia	Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre	Petaling Jaya	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse effect after using the serum.	Based on adverse effect occurrence on participants that occur during study period (8 weeks)	Week 8
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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