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

15 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Brasil
    • São Paulo
      • Osasco, São Paulo, Brasil, 06023-070
        • Reclutamiento
        • Grupo Medcin
        • Contacto:
        • Investigador principal:
          • Sergio Schalka

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: 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.
Experimental: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Facial Hyperpigmentation Assessed by Chromameter (L* Parameter)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the Number of Facial Pigmented Lesions Assessed by VISIA® Imaging System
Periodo de tiempo: 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
Periodo de tiempo: 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®
Periodo de tiempo: 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®
Periodo de tiempo: 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®
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Brainfarma Industria Química e Farmacêutica S/A

Investigadores

  • Investigador principal: Sergio Schalka, Grupo Medcin

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de julio de 2026

Finalización primaria (Estimado)

21 de enero de 2027

Finalización del estudio (Estimado)

21 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

12 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de agosto de 2026

Publicado por primera vez (Actual)

17 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 26-0161-05

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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