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

• Sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05986123
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Topical cream Z for PIH	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Safety and Efficacy of Topical Cream Containing Natural Plant Extracts, Niacinamide, and Arbutin for Post-inflammatory Hyperpigmentation Skin Among Malaysians
• Actual Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 31, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Topical cream for PIH The topical cream contain combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract.	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

Outcome Measures

Primary Outcome Measures

1. Change in skin spot level [Baseline, week 4, week 8, week 12, week 16 and week 20.]

   Skin spot will be assessed using JANUS III skin analyzer.

2. Change in hyperpigmentation score [Baseline, week 4, week 8, week 12, week 16 and week 20.]

   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).

3. Adverse effect after using the topical cream. [Week 20]

   Based on adverse effect occurrence on participants that occur during study period (20 weeks)

Secondary Outcome Measures

1. Participant satisfaction after using the topical cream for 20 weeks. [Week 20]

   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

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

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.

• Responsible Party: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
• ClinicalTrials.gov Identifier: NCT05986123
• Other Study ID Numbers: UMRAMREC002-23
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre: Aesthetic; Cosmetic; Post-inflammatory hyperpigmentation (PIH)
• Additional relevant MeSH terms: Hyperpigmentation

Study Results

No Results Posted as of Aug 14, 2023