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

NCT05986123 | Completed

• 1 other identifier: UMRAMREC002-23
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.To determine the efficacy of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.
2. 2.To investigate the safety of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.
3. 3.To assess the participants satisfaction of using topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among Malaysians.

Conditions

Healthy

Keywords

Aesthetic; Cosmetic; Post-inflammatory hyperpigmentation (PIH)

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• Adverse effect after using the topical cream.

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

  Week 20

Secondary Outcomes (1)

• Participant satisfaction after using the topical cream for 20 weeks.

  Week 20

Study Arms (1)

Topical cream for PIH

OTHER

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

Interventions

Topical cream Z for PIH OTHER

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

Topical cream for PIH

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• USMARI Research & Innovation Centre: lead

Study Sites (1)

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Petaling Jaya, Selangor, 47810, Malaysia

Location

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Prolactin Release-Inhibiting Factors

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)