Actively Recruiting
Evaluation of the Efficacy and Tolerability of the Tested Formula BID After 3 Months in the Treatment of Facial Hyperpigmentation of 3 Origins: Melasma, Acne Induced Post-Inflammatory Hyperpigmentation and Solar Lentigo
Led by Cosmetique Active International · Updated on 2024-08-06
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new cosmetic formula to treat facial hyperpigmentation caused by three conditions: mild to moderate melasma, mild to moderate acne-induced post-inflammatory hyperpigmentation, and solar lentigo. This open, single-center study aims to assess the product's effectiveness, cosmetic acceptability, and its impact on reducing stigma associated with these skin conditions. The study follows ethical guidelines and good clinical practices to ensure proper conduct and data analysis. The study involves applying the tested product twice daily, in the morning and evening, along with using sunscreen in the morning and at midday for three months. Participants are grouped based on their specific type of hyperpigmentation: melasma, acne-induced hyperpigmentation without active acne, or solar lentigo. Each participant will use the product under normal conditions, with before-and-after comparisons to evaluate changes. Participants will be assessed at the start and after 84 days to measure skin changes using various pigmentation scores specific to each condition. Researchers will also use colorimetry to quantify skin color changes. Safety data will be recorded but not statistically analyzed. The study expects to include about 20 patients per group and will observe participants throughout the three-month treatment period to monitor efficacy and tolerability.
CONDITIONS
Brief Title
Efficacy and Tolerability of Tested Formula After 3 Months of Treatment of Facial Hyperpigmentation of 3 Origins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of all phototypes
- Adults with one of the following facial pigmentary conditions: mild to moderate melasma (epidermal or mixed), mild to moderate acne-induced post-inflammatory hyperpigmentation without active acne, or solar lentigo
- Female participants of childbearing potential must use reliable contraception and agree not to change it during the study
- Participants must agree to avoid exposure to natural or artificial ultraviolet radiation during the study
You will not qualify if you...
- Female participants who gave birth less than 3 months before the study, are pregnant, breastfeeding, or planning pregnancy during the study
- Male participants with beard or facial hair interfering with clinical evaluation
- Participants with inflammatory dermatosis of the face such as seborrheic dermatitis or rosacea
- Participants with severe or dermal melasma
- Participants with facial pigmentary disorders other than those specified in inclusion criteria
- Participants who used topical depigmenting agents or certain systemic treatments affecting pigmentation within 1 month prior to baseline
- Participants who used drugs known to induce pigmentation within 1 month prior to baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants apply the tested product twice a day and sunscreen daily to the face for 3 months to treat facial hyperpigmentation.
Visits at baseline and periodically during treatment for assessment
Trial Site Locations
Total: 1 location
1
National Skin Care Centre
Singapore, Singapore
Actively Recruiting
Research Team
S
Steven Thng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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