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

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ClinicalTrials.gov Identifier: NCT05986123
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Arbutin

Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Change in skin spot level [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05986123


Locations
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Malaysia
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre Recruiting
Petaling Jaya, Selangor, Malaysia, 47810
Contact: SITI NUR HANIS MAMOOD    +60167572670    hanis@usmari.org.my   
Contact: Nur Izzati Abdul Rashid    +60167252670    izzati@usmari.org.my   
Sponsors and Collaborators
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
More Information
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Responsible Party: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
ClinicalTrials.gov Identifier: NCT05986123    
Other Study ID Numbers: UMRAMREC002-23
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Hyperpigmentation
Pigmentation Disorders
Skin Diseases