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

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Status: Enrolling

Conditions: Healthy

Treatments: Other: Topical cream Z for PIH

Study type: Interventional

Funder types: Industry

Identifiers

NCT05986123

UMRAMREC002-23

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Topical cream for PIH

Other group

Description:

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

Treatment:

Other: Topical cream Z for PIH