Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women

2 de junio de 2026 actualizado por: Hospital Israelita Albert Einstein

The goal of this clinical trial is to evaluate whether the use of dermocosmetics containing Bioceramides and Niacinamide can improve post-inflammatory hyperpigmentation and promote positive impacts on self-esteem and quality of life in Brazilian Black women with facial hyperpigmentation (Fitzpatrick skin types IV to VI).

The main questions it aims to answer are:

  • Does the treatment improve hyperpigmentation severity as measured by HASI and IGA scores?
  • Does the treatment improve participants' self-esteem and quality of life as assessed by MELASQoL and DLQI questionnaires?

Participants will:

  • Use a standardized skincare routine including cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen for 12 weeks.
  • Attend study visits at baseline, week 6, and week 12.
  • Undergo standardized facial photography and clinical assessments by specialists at baseline, week 6, and week 12.
  • Complete questionnaires related to self-esteem and quality of life at baseline, week 6, and week 12.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

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

  • Nombre: Jessica Andrade-Silva, PhD
  • Número de teléfono: +55975295921
  • Correo electrónico: jessica.as@einstein.br

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Brasil
    • São Paulo
      • São Paulo, São Paulo, Brasil, 05652-900
        • Reclutamiento
        • Hospital israelita Albert Einstein
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Bruna Cestari de Azevedo, PhD

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

No

Descripción

Inclusion Criteria:

  • Female participants aged 18 to 55 years
  • Clinical diagnosis of facial post-inflammatory hyperpigmentation (PIH)
  • Self-identified as Black (including "preta" or "parda")
  • Fitzpatrick skin types IV to VI
  • Employees, students, or affiliated personnel of Hospital Israelita Albert Einstein (including contractors and fellows), recruited from institution units
  • Willing and able to comply with all study procedures and attend all scheduled visits
  • Able and willing to provide written informed consent and authorization for image use

Exclusion Criteria:

  • Pregnant or breastfeeding women, or those planning pregnancy during the study period
  • Type 1 diabetes mellitus or related complications (e.g., nephropathy, dermatological conditions associated with diabetes, history of hypoglycemia, diabetic ketoacidosis, or hyperosmolar coma)
  • Known or suspected intolerance to similar cosmetic products
  • History of atopy or allergic reactions to cosmetic products
  • Personal or family history of skin cancer
  • Active skin conditions or lesions affecting the face
  • Facial marks or scars that may interfere with assessments
  • Skin irritation due to recent sun exposure
  • Excessive sun or UV exposure, including artificial tanning, within the past month
  • Use of facial cosmetic products within 7 days before screening
  • Use of topical or systemic treatments within 1 month before screening
  • Use of depigmentation treatments within 3 months before screening
  • Use of dermocosmetic treatments for PIH within 3 months before screening
  • Facial dermatological or aesthetic procedures within 2 weeks before screening
  • Use of corticosteroids, anticoagulants, or immunosuppressive drugs
  • Score ≥5 indicating anxiety or depression on Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder scale (GAD-7)
  • Any other condition that, in the investigator's judgment, may compromise study participation or results (to be documented in the medical record)

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention

Participants will receive a standardized facial skincare regimen to be used daily for 12 weeks, including a cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen (non-investigational). Products will be used daily, with cleanser twice daily, moisturizer in the morning, serum at night, and sunscreen twice daily.

Participants will undergo evaluations at baseline, week 6, and week 12, including standardized photography and assessment using Hyperpigmentation Area Severity Scale (HASI) and Investigator's Global Assessment (IGA). Quality of life will be assessed with Melasma Quality of Life Scale (MelasQoL) and Dermatology Life Quality Index (DLQI). Participants will complete daily diaries to record product use and any reactions during the study, and will assess perceived product efficacy at the final visit.
Droga: Niacinamide and Bioceramide-Based Skincare Regimen
A standardized facial skincare regimen containing a cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen. The products are intended for daily use, with cleanser applied twice daily, moisturizer applied in the morning, serum applied at night, and sunscreen applied twice daily.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI)
Periodo de tiempo: Baseline, Week 6, and Week 12
The Hyperpigmentation Area Severity Scale (HASI), adapted from the Melasma Area Severity Index (MASI), will be used to evaluate pigmentation severity. The face will be divided into four regions (forehead, right malar, left malar, and chin). Hyperpigmentation severity will be assessed based on three components: pigmentation intensity and homogeneity (both scored from 0 to 4), and the affected area (scored from 0 to 6). A weighted sum will be calculated for each region using the following formula: HASI = 0.3 × (area score) × (intensity + homogeneity) for the forehead and malar regions, and 0.1 × (area score) × (intensity + homogeneity) for the chin. The total HASI score will be obtained by summing all regions, ranging from 0 to 48, with higher scores indicating greater hyperpigmentation severity.
Baseline, Week 6, and Week 12
Visual Assessment of Post-Inflammatory Hyperpigmentation Using Standardized Facial Photography
Periodo de tiempo: Baseline, Week 6, and Week 12
Standardized facial photographs will be obtained at each study visit and will be evaluated by a dermatologist to assess post-inflammatory hyperpigmentation. Images will be captured under visible light using a standardized protocol (Rossi et al., 2011), including three facial views (frontal, left 45°, and right 45°). The face will be divided into seven regions for visual analysis and quantification of pigmented areas using ImageJ software (version 1.45p, NIH). All photographs will be acquired using consistent camera settings, lighting conditions, and participant positioning throughout the study to ensure comparability.
Baseline, Week 6, and Week 12
Change in Hyperpigmentation Severity Assessed by Investigator's Global Assessment (IGA)
Periodo de tiempo: Baseline, Week 6, and Week 12
The Investigator's Global Assessment (IGA) is a visual assessment that will be used to provide an overall evaluation of post-inflammatory hyperpigmentation severity. Assessments will be performed by a dermatologist using a 6-point scale ranging from 0 to 5, according to morphological characteristics of pigmentation: 0 = no hyperpigmentation; 1 = almost clear; 2 = mild but noticeable hyperpigmentation; 3 = moderate hyperpigmentation (medium brown); 4 = severe hyperpigmentation (dark brown); and 5 = very severe hyperpigmentation (very dark brown to nearly black). Higher scores will indicate greater severity of pigmentation.
Baseline, Week 6, and Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Quality of Life Assessed by Melasma Quality of Life Scale (MelasQoL)
Periodo de tiempo: Baseline, Week 6, and Week 12
The Melasma Quality of Life Scale (MelasQoL) will be used to assess quality of life related to post-inflammatory hyperpigmentation. The questionnaire consists of 10 items divided into three domains: emotional well-being, social life, and self-esteem/daily activities. Each item is scored from 1 (not bothered at all) to 7 (constantly bothered), with higher scores indicating worse quality of life. The MelasQoL is a validated instrument for assessing the impact of melasma and other pigmentary disorders on patients' quality of life.
Baseline, Week 6, and Week 12
Change in Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
Periodo de tiempo: Baseline, Week 6, and Week 12
The Dermatology Life Quality Index (DLQI) will be used to assess quality of life and self-esteem related to post-inflammatory hyperpigmentation. The questionnaire consists of 10 items covering six domains: symptoms, emotions, daily activities, work/school, social functioning, and treatment. Each item is scored from 0 (not at all/not relevant) to 3 (very much), with total scores ranging from 0 to 30. Higher scores indicate greater impairment in quality of life.
Baseline, Week 6, and Week 12

Colaboradores e Investigadores

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

Patrocinador

Hospital Israelita Albert Einstein

Colaboradores

COTY BRASIL COMERCIO S.A.

Investigadores

  • Investigador principal: Bruna Cestari de Azevedo, PhD, Hospital israelita Albert Einstein

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)

19 de marzo de 2026

Finalización primaria (Estimado)

31 de octubre de 2026

Finalización del estudio (Estimado)

31 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

25 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

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

2 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • COTY_10772

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

producto fabricado y exportado desde los 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. .

Suscribir