Safety and Efficacy of Topical Cream for Post-inflammatory Hyperpigmentation Skin Among Malaysians

Healthy Clinical Trial

Official title:

Safety and Efficacy of Topical Cream Containing Natural Plant Extracts, Niacinamide, and Arbutin for Post-inflammatory Hyperpigmentation Skin Among Malaysians

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986123
• Other study ID #: UMRAMREC002-23
• 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 was conducted to determine safety and efficacy of topically applied cream containing combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract for its skin brightening effect on post-inflammatory hyperpigmentation among the Malaysian population. The study duration is 20 weeks and the skin assessment will be carried out at baseline, week 4, week 8, week 12, week 16 and week 20.The main questions this study aims to answer are: 1. To determine the efficacy of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians. 2. To investigate the safety of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians. 3. To assess the participants satisfaction of using topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Malaysia citizen
• Healthy adult, aged between 18 to 40 years old.
• Participants who have post-inflammatory hyperpigmentation on skin

Exclusion Criteria:

• Participants with skin disorders such as skin infection or skin inflammation.
• Participants who have undergone any skin and cosmetic treatments such as dermal fillers, botox, laser, chemical peels within the last 3 months.
• Participant who is taking isotretinoin for the past 6 or 12 months and immunocompromised patients.
• Pregnant, breastfeeding women or planned for pregnancy during the study period.

Related Conditions & MeSH terms

• Healthy
• Hyperpigmentation

Intervention

Other:
• Topical cream Z for PIH
The topical cream Z contain combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract. Participants will used the topical cream twice daily for 20 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	Change in skin spot level	Skin spot will be assessed using JANUS III skin analyzer.	Baseline, week 4, week 8, week 12, week 16 and week 20.
Primary	Change in hyperpigmentation score	The hyperpigmented skin area will be assessed based on Modified Melasma Area and Severity Index (mMASI) Score. Scoring system of mMASI score: A, Area of involvement is rated from 0 to 6: (0 indicates absent, 1=<10%, 2= 10% to 90%, 3= 30%-49%, 4= 50%-69%, 5= 70% to 89%, 6=90% to 100%). D, Darkness is rated from 0 to 4: 0= absent, 1=slight hyperpigmentation, 2= mild hyperpigmentation, 3= marked hyperpigmentation, 4=severe hyperpigmentation. Total mMASI score range is 0 (clear) to 24 (most severe melasma) and calculated by adding scores (A and D) for 4 areas of the face. The formula for mMASI score = 0.3×A(forehead)×D (forehead)+0.3×A (left malar) ×D (left malar) + 0.3×A(right malar)×D (right malar)+0.1×A(chin)×D (chin).	Baseline, week 4, week 8, week 12, week 16 and week 20.
Primary	Adverse effect after using the topical cream.	Based on adverse effect occurrence on participants that occur during study period (20 weeks)	Week 20
Secondary	Participant satisfaction after using the topical cream for 20 weeks.	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 20