HyperpigmentationHYPERPIGNCT07769268
Efficacy Evaluation of a Cosmetic Product for Facial Hyperpigmentation
A study testing Blancy Pro in people with Hyperpigmentation and Melasma (Facial Melasma), run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation, Melasma (Facial Melasma)
- What is being tested?
- Blancy Pro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Jul 2026to 21 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Grupo Medcin
Osasco, São Paulo, 06023-070
Camila Canale, +55 (11) 98343 6952, camila.canale.ext@medcin.com.br
Sergio Schalka
About this study
Official title: Evaluation of the Efficacy of a Cosmetic Product for the Reduction of Facial Hyperpigmentation: A Clinical, Subjective, and Instrumental Study
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.
- Conditions
- Hyperpigmentation, Melasma (Facial Melasma)
- Being tested
- Blancy Pro
- Medical subject headings
- Hyperpigmentation, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blancy ProOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Facial Hyperpigmentation Group | Experimental | 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. Receives: Other: Blancy Pro |
| Melasma Group | Experimental | 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. Receives: Other: Blancy Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0), Day 30, Day 60, and Day 90
Secondary outcomes (10)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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®.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Baseline (Day 0), Day 30, Day 60, and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start13 Jul 2026
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergio Schalka, Principal investigator, Grupo Medcin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769268
- Sponsor's protocol ID
- 26-0161-05
- Acronym
- HYPERPIG
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Cosmetic Product for the Reduction of Facial Hyperpigmentation: A Clinical, Subjective, and Instrumental Study
- ClinicalTrials.gov ID
- NCT07769268
- Acronym / sponsor ID
- HYPERPIG / 26-0161-05
- Conditions
- Hyperpigmentation, Melasma (Facial Melasma)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Jan 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial Hyperpigmentation Group | Experimental | Other: Blancy ProFemale 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. |
| Melasma Group | Experimental | Other: Blancy ProFemale 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blancy ProBlancy 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. | Other | Facial Hyperpigmentation Group, Melasma Group |
Primary outcome
Change in Facial Hyperpigmentation Assessed by Chromameter (L* Parameter)
Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90
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.
10 secondary outcomes
Clinical Improvement of Facial Hyperpigmentation Assessed by a 5-Point Scale
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)
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
Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90
Change in Facial Skin Tone Uniformity Assessed by VISIA® Image Analysis
Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90
Change in Facial Skin Hydration Assessed by Corneometer®
Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90
Maintenance of Skin pH Assessed by Skin pHmeter®
Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90
Maintenance of Skin Barrier Function Assessed by Tewameter®
Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90
Safety of the Investigational Product Under Normal Conditions of Use
Time frame: Day 30, Day 60, and Day 90
Participant-Perceived Efficacy and Product Performance Assessed by Subjective Questionnaire
Time frame: Day 14, Day 30, Day 60, and Day 90
Change in Quality of Life Assessed by the MelasQoL Questionnaire
Time frame: Baseline (Day 0), Day 30, Day 60, and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergio Schalka principal investigator
Grupo Medcin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blancy Pro in people with Hyperpigmentation and Melasma (Facial Melasma), run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Layane Melody Da Silva Reis Cavalcante (+55 (11) 4507-2183, layane.reis@brainfarma.ind.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Facial Hyperpigmentation Assessed by Chromameter (L* Parameter) (time frame: Baseline (Day 0), Day 30, Day 60, and Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.