A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants (El Porto Ex-US)
25 de junio de 2026 actualizado por: Kenvue Brands LLC
A Monocentric and Open-Label Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Research Participants
The study aims to evaluate the efficacy of a facial sunscreen under two experimental conditions-untinted and tinted-in improving facial spots (melasma and solar lentigines/post-inflammatory hyperpigmentation) after 8 weeks of product use under normal conditions by adult participants.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
152
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: Kenvue Global Clinical Operations
- Número de teléfono: 18779295131
- Correo electrónico: KenvueClinical_KV@kenvue.com
Ubicaciones de estudio
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São Paulo
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Campinas, São Paulo, Brasil, 13084-791
- Reclutamiento
- ALS Beauty & Personal Care Ltda
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Contacto:
- Gabrielli Brianezi
- Número de teléfono: +551937898600
- Correo electrónico: gabrielli.brianezi@alsglobal.com
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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
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Able to understand and follow study instructions
- Fitzpatrick skin types I-VI
Presence of facial hyperpigmentation, such as:
- Mild to moderate melasma, or
- Visible dark spots (e.g., solar lentigines or post-inflammatory hyperpigmentation)
- Willing to comply with study procedures and product use
- For subjects in applicable groups: willing to use assigned sunscreen product
Exclusion Criteria:
- Known sensitivity or allergy to cosmetic or skincare products
- Skin conditions or lesions in the study area that could interfere with evaluation (e.g., active dermatitis, infections, significant irritation, or extensive scarring)
- Use of medications or products that may interfere with study evaluations
- Recent cosmetic or dermatological procedures in the study area (e.g., chemical peels, laser treatments, invasive procedures)
- Excessive sun exposure or use of tanning beds immediately prior to or during the study
- Pregnancy or intention to become pregnant during the study
- Participation in another clinical study within a recent period
- Any condition or situation that, in the investigator's judgment, may interfere with study participation or evaluation of results
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Group I: Melasma/Untinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
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Experimental: Group I: Melasma/Tinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
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Experimental: Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Untinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
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Experimental: Group II: Solar Lentigo and Post-Inflammatory Hyperpigmentation / Tinted
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Participants will apply the facial sunscreen on the face at least twice daily for 56 days
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation
Periodo de tiempo: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Instrumental measurements with the Chroma Meter CR 400 (Konica Minolta)
Periodo de tiempo: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Measurements will be taken using the Chroma Meter® CR 400 to evaluate the color intensity of the dark spot (Melasma, Solar Lentigo, or Post-Inflammatory Hyperpigmentation) in comparison to the measurement of an adjacent area (without a spot).
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Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Capture of facial images using the Visia-CR® Facial Imaging Booth (Canfield Scientific, Inc.)
Periodo de tiempo: Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Facial images will be captured using the Visia CR® Facial Imaging Booth (Canfield Scientific, Inc.) for analysis of the intensity and size of the spot (Melasma, Solar Spot, or Post-Inflammatory Hyperpigmentation), as well as the overall uniformity of skin tone.
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Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Participants' quality of life regarding facial spots for participants with Melasma assessed through a Quality of Life Questionnaire (MELASQoL)
Periodo de tiempo: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Melasma Quality of Life Scale (MELASQoL) will only be answered by participants enrolled in Melasma group. The participant will answer a questionnaire with 10 questions regarding the condition of their skin, using a rating scale from 1 to 7, in which: 1 means "not at all bothered" and 7 means "bothered all the time". A total score will be generated by summing the scores of the 10 questions answered by the participant. The total score ranges from 10 to 70. The lower the score, the better the participant's quality of life. |
Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Participants' quality of life regarding facial spots for participants with Solar Lentigo or Post-Inflammatory Hyperpigmentation assessed through a Quality of Life Questionnaire (DLQI)
Periodo de tiempo: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Dermatology Life Quality Index (DLQI) will only be answered by participants selected for the Solar Lentigo/PIH Group.
The participant will answer a questionnaire with 10 questions regarding the impact of their skin on their quality of life.
Each question is scored on a four-point Likert scale: very much = 3 points, much = 2 points, a little = 1 point and nothing/not relevant = 0 points.
Questions answered as nothing and not relevant are equivalent to 0 points.
The total score ranges from 0 to 30.
The lower the score, the better the participant's quality of life.
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Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Perceived efficacy assessed through perception questionnaires completed by the research participants
Periodo de tiempo: After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Participants will answer a questionnaire evaluating their individual opinion about the Investigational Product used.
Questionnaire consists of 9 questions which should be answered in a 5-point scale of agreement (such as ranging from "Strongly Disagree" to "Strongly Agree").
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After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use
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Open emotional testimonial written by the participant at the end of IP use
Periodo de tiempo: After Visit 4 (56+2 days) of IP use
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Consists of an open-ended, narrative question in which the participant provides a brief statement regarding their experience with the use of their respective Investigational Product.
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After Visit 4 (56+2 days) of IP use
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
2 de junio de 2026
Finalización primaria (Estimado)
25 de septiembre de 2026
Finalización del estudio (Estimado)
25 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
1 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
23 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CS2026SK100350
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .