Efficacy Evaluation of a Cosmetic Product for Facial Hyperpigmentation

Brainfarma Industria Química e Farmacêutica S/A40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hyperpigmentation Melasma (Facial Melasma)

Interventions

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Willingness to comply with study procedures and be available for remote contact (telehealth) at scheduled times. * Ability to understand the study requirements, provide written informed consent, and sign the informed consent form. Exclusion Criteria: * 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. * Active skin diseases and/or lesions in the assessment area. * Immunosuppression due to medication use or active disease. * Uncontrolled endocrine disorders. * Relevant medical history or current evidence of alcohol or substance abuse. * Known history or suspected intolerance to products of the same category as the study product. * Intense sun exposure within 15 days prior to assessment. * Aesthetic or dermatological treatments within 4 weeks prior to assessment. * Any other condition that, in the investigator's opinion, may interfere with study participation or justify exclusion from the study.

Outcomes

Primary Outcomes

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 90

Secondary Outcomes

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 90

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 90

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 90

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 90

Change in Facial Skin Hydration Assessed by Corneometer®

Evaluation of the ability of the investigational product to improve facial skin hydration in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through instrumental measurements obtained using the Corneometer® device.

Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90

Maintenance of Skin pH Assessed by Skin pHmeter®

Evaluation of the maintenance of skin pH during use of the investigational product in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through instrumental measurements obtained using the Skin pHmeter®.

Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90

Maintenance of Skin Barrier Function Assessed by Tewameter®

Evaluation of the maintenance of skin barrier function during use of the investigational product through instrumental measurements of transepidermal water loss (TEWL) using the Tewameter® device.

Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90

Safety of the Investigational Product Under Normal Conditions of Use

Evaluation of the safety and tolerability of the investigational product under normal conditions of use in the target population through clinical monitoring of adverse reactions and tolerability assessments.

Time frame: Day 30, Day 60, and Day 90

Participant-Perceived Efficacy and Product Performance Assessed by Subjective Questionnaire

Evaluation of the perceived efficacy and performance of the investigational product from the participants' perspective using a Likert Scale questionnaire administered under real-world conditions of use. The Likert Scale ranges from "Strongly Disagree" to "Strongly Agree".

Time frame: Day 14, Day 30, Day 60, and Day 90

Change in Quality of Life Assessed by the MelasQoL Questionnaire

Evaluation of the impact of treatment on the quality of life of participants with melasma using the Melasma Quality of Life Scale (MelasQoL). The MelasQoL assesses the impact of melasma on daily life and well-being using ordered response categories ranging from "Not bothered at all" to "Bothered all of the time." Responses indicating less bother reflect better quality of life, while responses indicating greater bother reflect worse quality of life.

Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90

Efficacy Evaluation of a Cosmetic Product for Facial Hyperpigmentation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts