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Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

Primary Purpose

Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
Sponsored by
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy focused on measuring Aesthetic, Cosmetic, Post-inflammatory hyperpigmentation (PIH)

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA

Arm Description

This serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA.

Outcomes

Primary Outcome Measures

Adverse effect after using the serum.
Based on adverse effect occurrence on participants that occur during study period (8 weeks)

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 1, 2023
Last Updated
August 15, 2023
Sponsor
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05998200
Brief Title
Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin
Official Title
Safety of Serum Containing Alpha Hydroxy Acid (AHA) and Polyglutamate Acid Derivatives for Post-Inflammatory on Hyperpigmentation Skin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Aesthetic, Cosmetic, Post-inflammatory hyperpigmentation (PIH)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
Arm Type
Other
Arm Description
This serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA.
Intervention Type
Other
Intervention Name(s)
Serum with low concentration AHA (1% Glycolic acid and Lactic acid) and PGA
Intervention Description
Participants will used the serum twice daily for 8 weeks
Primary Outcome Measure Information:
Title
Adverse effect after using the serum.
Description
Based on adverse effect occurrence on participants that occur during study period (8 weeks)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in skin moisture level
Description
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
Title
Change in skin spot level
Description
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
Title
Change in skin pores level
Description
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
Title
Change in skin tone level
Description
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
Title
Participant satisfaction after using the serum for 8 week.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47810
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SITI NUR HANIS MAMOOD
Phone
+60167572670
Email
hanis@usmari.org.my
First Name & Middle Initial & Last Name & Degree
Nur Izzati Abdul Rashid
Phone
+60167252670
Email
izzati@usmari.org.my

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin

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