Efficacy Evaluation of a Cosmetic Product for Facial Hyperpigmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-60
SponsorBrainfarma Industria Química e Farmacêutica S/A
About this trial
This is a single-center, single-blind clinical study designed to evaluate the efficacy of a depigmenting gel cream through clinical, subjective, and instrumental assessments. A total of 40 female participants, aged 30 to 60 years, will be enrolled and followed for 90 days while using the study product.Participants will be assigned to one of two groups. Group I will include 20 participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, representing Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Group II will include 20 participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), representing Fitzpatrick skin phototypes II to V.
The study aims to evaluate the product's effectiveness in reducing facial hyperpigmentation and improving skin appearance over the treatment period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female participants aged 30 to 60 years.
Group I: Participants with Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype category. Participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines.
Group II: Participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), and Fitzpatrick skin phototypes II to V.
Willingness to comply with all study procedures and attend scheduled on-site visits and assessments.
Disqualifiers
Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
Skin conditions or marks in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
History of atopic conditions or allergy to cosmetic products.
Trial design
Design model
Parallel
Treatments tested in this trial
Blancy Pro
Other interventionBlancy Pro is a depigmenting gel cream intended to reduce facial hyperpigmentation and improve skin appearance. Participants will use the product for 90 days, and efficacy will be assessed through clinical, subjective, and instrumental evaluations.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Facial Hyperpigmentation GroupExperimental treatment 1 intervention
Group B: Melasma GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Facial Hyperpigmentation Assessed by Chromameter (L* Parameter)
Evaluation of the efficacy of the investigational product in improving facial hyperpigmentation in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through colorimetric measurements obtained using the Chromameter® device. Changes in the L\* parameter will be assessed over time, with higher values indicating skin lightening.
Time frame
Baseline (Day 0), Day 30, Day 60, and Day 90Secondary outcomes
1
Clinical Improvement of Facial Hyperpigmentation Assessed by a 5-Point Scale
Evaluation of the efficacy of the investigational product in improving facial hyperpigmentation in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through clinical assessment using a 5-point evaluation scale, ranging from 1 (Very Severe) to 5 (Absent). Higher scores indicate less severe pigmentation and a better clinical outcome.
Time frame
Baseline (Day 0), Day 30, Day 60, and Day 902
Change in Melasma Severity Assessed by the Modified Melasma Area and Severity Index (mMASI)
Evaluation of the efficacy of the investigational product in improving melasma in participants diagnosed with melasma using the Modified Melasma Area and Severity Index (mMASI). The mMASI assesses melasma severity across four facial regions: forehead, right malar region, left malar region, and chin, weighted according to their proportional facial areas. Scores range from 0 to 24, with 0 indicating no melasma and 24 indicating the most severe melasma. Higher scores indicate worse disease severity, and lower scores indicate improvement. The mMASI score is calculated using the formula: mMASI = 0.3(AF×PF) + 0.3(AMD×PMD) + 0.3(AME×PME) + 0.1(AM×PM).
Time frame
Baseline (Day 0), Day 30, Day 60, and Day 903
Change in the Number of Facial Pigmented Lesions Assessed by VISIA® Imaging System
Evaluation of the efficacy of the investigational product in reducing the number of facial pigmented lesions in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through image analysis using the VISIA® imaging system (Canfield Software).
Time frame
Baseline (Day 0), Day 30, Day 60, and Day 904
Change in Facial Skin Tone Uniformity Assessed by VISIA® Image Analysis
Evaluation of the efficacy of the investigational product in improving facial skin tone uniformity in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through image analysis using the VISIA® system and Image-Pro Plus software.
Time frame
Baseline (Day 0), Day 30, Day 60, and Day 90Sponsors and contacts
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Source ClinicalTrials.gov