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Efficacy Evaluation of a Cosmetic Product for Facial Hyperpigmentation (HYPERPIG)

15 september 2026 bijgewerkt door: Brainfarma Industria Química e Farmacêutica S/A

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Brazilië
    • São Paulo
      • Osasco, São Paulo, Brazilië, 06023-070

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Facial Hyperpigmentation Group
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.
Ander: 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.
Experimenteel: Melasma Group
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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Facial Hyperpigmentation Assessed by Chromameter (L* Parameter)
Tijdsspanne: 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.
Baseline (Day 0), Day 30, Day 60, and Day 90

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the Number of Facial Pigmented Lesions Assessed by VISIA® Imaging System
Tijdsspanne: Baseline (Day 0), Day 30, Day 60, and Day 90
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).
Baseline (Day 0), Day 30, Day 60, and Day 90
Change in Facial Skin Tone Uniformity Assessed by VISIA® Image Analysis
Tijdsspanne: Baseline (Day 0), Day 30, Day 60, and Day 90
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.
Baseline (Day 0), Day 30, Day 60, and Day 90
Change in Facial Skin Hydration Assessed by Corneometer®
Tijdsspanne: Baseline (Day 0), Day 30, Day 60, and Day 90
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.
Baseline (Day 0), Day 30, Day 60, and Day 90
Maintenance of Skin pH Assessed by Skin pHmeter®
Tijdsspanne: Baseline (Day 0), Day 30, Day 60, and Day 90
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®.
Baseline (Day 0), Day 30, Day 60, and Day 90
Maintenance of Skin Barrier Function Assessed by Tewameter®
Tijdsspanne: Baseline (Day 0), Day 30, Day 60, and Day 90
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.
Baseline (Day 0), Day 30, Day 60, and Day 90
Safety of the Investigational Product Under Normal Conditions of Use
Tijdsspanne: Day 30, Day 60, and Day 90
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.
Day 30, Day 60, and Day 90
Clinical Improvement of Facial Hyperpigmentation Assessed by a 5-Point Scale
Tijdsspanne: 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 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.
Baseline (Day 0), Day 30, Day 60, and Day 90
Change in Melasma Severity Assessed by the Modified Melasma Area and Severity Index (mMASI)
Tijdsspanne: Baseline (Day 0), Day 30, Day 60, and Day 90
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).
Baseline (Day 0), Day 30, Day 60, and Day 90
Participant-Perceived Efficacy and Product Performance Assessed by Subjective Questionnaire
Tijdsspanne: Day 14, Day 30, Day 60, and Day 90
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".
Day 14, Day 30, Day 60, and Day 90
Change in Quality of Life Assessed by the MelasQoL Questionnaire
Tijdsspanne: Baseline (Day 0), Day 30, Day 60, and Day 90
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.
Baseline (Day 0), Day 30, Day 60, and Day 90

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Brainfarma Industria Química e Farmacêutica S/A

Onderzoekers

  • Hoofdonderzoeker: Sergio Schalka, Grupo Medcin

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 juli 2026

Primaire voltooiing (Geschat)

21 januari 2027

Studie voltooiing (Geschat)

21 januari 2027

Studieregistratiedata

Eerst ingediend

12 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 augustus 2026

Eerst geplaatst (Werkelijk)

17 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

15 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26-0161-05

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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