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

NCT ID: NCT05986123

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Topical cream for PIH

The topical cream contain combination of niacinamide, arbutin, Scutellaria Baicalensis Root Extract, Centella Asiatica Extract and Camellia Sinensis Leaf Extract.

Group Type OTHER

Topical cream Z for PIH

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Petaling Jaya, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Facility Contacts

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SITI NUR HANIS MAMOOD

Role: primary

+60167572670

Nur Izzati Abdul Rashid

Role: backup

+60167252670

Other Identifiers

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UMRAMREC002-23

Identifier Type: -

Identifier Source: org_study_id

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