An interventional study of Blancy Pro in Hyperpigmentation and Melasma (Facial Melasma), sponsored by Brainfarma Industria Química e Farmacêutica S/A. Recruiting at 1 site in Brazil. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Brainfarma Industria Química e Farmacêutica S/A (part of Hypera Pharma) · Not applicable, Interventional, and Treatment
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.
127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.
This study's planned enrollment of 40 is above the median of 32 across 113 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Brainfarma Industria Química e Farmacêutica S/A is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Female participants aged 30 to 60 years with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Participants will use the depigmenting gel cream for 90 days.
Other: Blancy Pro
Female participants aged 30 to 60 years with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), Fitzpatrick skin phototypes II to V. Participants will use the depigmenting gel cream for 90 days.
Other: Blancy Pro
Blancy 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.
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
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
Plan to share: No — No plan has been established to share individual participant data (IPD) collected during this study. Participant confidentiality and privacy will be protected in accordance with applicable regulations and institutional policies.
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