Healthy
Conditions
Keywords
Aesthetic, Cosmetic, Post-inflammatory hyperpigmentation (PIH)
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.
Interventions
OTHERTopical 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
Sponsors
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Adverse effect after using the topical cream. | Week 20 | Based on adverse effect occurrence on participants that occur during study period (20 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Malaysia
Outcome results
None listed