NCT07769268

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jul 2026Jan 2027

Study Start

First participant enrolled

July 13, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2027

Last Updated

September 16, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 12, 2026

Last Update Submit

September 15, 2026

Conditions

HyperpigmentationMelasma (Facial Melasma)

Outcome Measures

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.

    Baseline (Day 0), Day 30, Day 60, and Day 90

Secondary Outcomes (10)

  • Clinical Improvement of Facial Hyperpigmentation Assessed by a 5-Point Scale

    Baseline (Day 0), Day 30, Day 60, and Day 90

  • Change in Melasma Severity Assessed by the Modified Melasma Area and Severity Index (mMASI)

    Baseline (Day 0), Day 30, Day 60, and Day 90

  • Change in the Number of Facial Pigmented Lesions Assessed by VISIA® Imaging System

    Baseline (Day 0), Day 30, Day 60, and Day 90

  • Change in Facial Skin Tone Uniformity Assessed by VISIA® Image Analysis

    Baseline (Day 0), Day 30, Day 60, and Day 90

  • Change in Facial Skin Hydration Assessed by Corneometer®

    Baseline (Day 0), Day 30, Day 60, and Day 90

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Other: Blancy Pro

Interventions

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.

Facial Hyperpigmentation GroupMelasma Group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified women who meet all study eligibility criteria.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo Medcin

Osasco, São Paulo, 06023-070, Brazil

RECRUITING

MeSH Terms

Conditions

HyperpigmentationMelanosis

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sergio Schalka

    Grupo Medcin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Layane Melody Da Silva Reis Cavalcante

CONTACT

+55 (11) 4507-2183layane.reis@brainfarma.ind.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 17, 2026

Study Start

July 13, 2026

Primary Completion (Estimated)

January 21, 2027

Study Completion (Estimated)

January 21, 2027

Last Updated

September 16, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

BR(1)