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 2024-07-12
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness, cosmetic acceptance, and impact on stigmatization of a tested serum formula used twice daily for three months in adults with mild to moderate facial hyperpigmentation. The study focuses on three types of hyperpigmentation: melasma, acne-induced post-inflammatory hyperpigmentation, and solar lentigo. These skin conditions result from excess melanin production due to factors like genetics, hormones, inflammation, acne, and sun exposure. Participants are divided into three groups based on their condition: those with mild to moderate melasma, those with mild to moderate acne-induced hyperpigmentation without active acne, and those with solar lentigo. All groups apply the serum formula to their face twice a day for three months. This open-label, single-center study compares skin condition before and after treatment to assess changes. During the study, participants will undergo assessments including Investigator's Global Assessment scores, pigment severity indexes specific to each condition, and colorimetry measurements to quantify skin color changes. The study tracks changes from baseline to day 84 to evaluate treatment effects. The trial follows ethical guidelines and includes safety monitoring throughout the participation period.
CONDITIONS
Brief Title
Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All skin phototypes are eligible
- Adults with only one of the following facial pigmentary conditions: mild to moderate melasma (epidermal or mixed), mild to moderate acne-induced post-inflammatory hyperpigmentation, or solar lentigo
- Female patients 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 (UV) radiation during the study
You will not qualify if you...
- Women who gave birth less than 3 months before the study, are pregnant, breastfeeding, or plan to become pregnant during the study
- Male patients with beard or facial hair that would interfere with evaluation
- Patients with inflammatory skin conditions on the face such as seborrheic dermatitis or rosacea
- Patients with severe or dermal melasma
- Patients with facial pigmentary disorders other than those listed in inclusion criteria
- Patients who used topical depigmenting agents or systemic treatments affecting pigmentation within 1 month prior to baseline
- Patients using 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 serum formula twice daily to the face for 3 months to treat facial hyperpigmentation.
Visits as needed for assessments during treatment
Trial Site Locations
Total: 1 location
1
Medcin Instituto da Pele Ltda
Osasco, Brazil
Actively Recruiting
Research Team
S
Sergio Schalka
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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