- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07622160
Efficacy Test of a Moisturizing and Anti-aging Facial Mask
Efficacy Test of a Moisturizing and Anti-aging Facial Mask for Skin Improvement
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a single-center, self-controlled human trial designed to evaluate the skin beauty effect of Moisturizing facial mask and Anti-aging facial mask.
Healthy adult participants aged above 18 years will be enrolled. Participants will be informed to apply the facial mask on whole face three times per week for 4 consecutive weeks. Skin measurement and self-assessment questionnaires will be conducted at baseline (before intake), after single use, and after continuous use for 2 and 4 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Pingdong, Taiwán
- Chia Nan University of Pharmacy & Science
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participants aged 18 years or older
Exclusion Criteria:
- Non-voluntary participants.
- Individuals diagnosed by a physician with skin diseases, liver cirrhosis, or chronic renal failure.
- Individuals with known allergies to cosmetics, medications, or foods.
- Pregnant or breastfeeding individuals.
- Individuals taking medications for chronic diseases.
- Students taught or supervised by the principal investigator.
Plan de estudios
¿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 |
|---|---|
|
Experimental: Hydrating Repairing Mask
|
Applying the facial mask three times per week for a continuous period of 4 weeks
Otros nombres:
|
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Experimental: Anti-aging Rejuvenating Mask
|
Applying the facial mask three times per week for a continuous period of 4 weeks
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The change of skin hydration
Periodo de tiempo: Change from Baseline skin hydration at 4 weeks
|
Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation.
Units: arbitrary Corneometer® units 0-120.
|
Change from Baseline skin hydration at 4 weeks
|
|
The change of skin redness
Periodo de tiempo: Change from Baseline skin redness at 4 weeks
|
Chroma Meter MM500 was utilized to measure face skin redness.
Units: a* value
|
Change from Baseline skin redness at 4 weeks
|
|
The change of skin texture
Periodo de tiempo: Change from Baseline skin texture at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin texture.
Units: arbitrary units
|
Change from Baseline skin texture at 4 weeks
|
|
The change of skin wrinkles
Periodo de tiempo: Change from Baseline skin wrinkles at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin wrinkles.
Units: arbitrary units
|
Change from Baseline skin wrinkles at 4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The change of transepidermal water loss (TEWL)
Periodo de tiempo: Change from Baseline TEWL at 4 weeks
|
Tewameter® TM300 (CK, Germany) was utilized to measure TEWL.
Units: g/hm²
|
Change from Baseline TEWL at 4 weeks
|
|
The change of skin tone
Periodo de tiempo: Change from Baseline skin tone at 4 weeks
|
Chroma Meter MM500 was utilized to measure face skin tone.
Units: Individual Typology Angle (ITA°)
|
Change from Baseline skin tone at 4 weeks
|
|
The change of skin pores
Periodo de tiempo: Change from Baseline skin pores at 4 weeks
|
VISIA Complexion Analysis was utilized to measure skin pores.
Units: arbitrary units
|
Change from Baseline skin pores at 4 weeks
|
|
The change of skin elasticity
Periodo de tiempo: Change from Baseline skin elasticity at 4 weeks
|
Skin elasticity (Softplus, Italy) was utilized to measure face skin elasticity.
Units: arbitrary units
|
Change from Baseline skin elasticity at 4 weeks
|
|
The change of skin collagen density
Periodo de tiempo: Change from Baseline skin collagen density at 4 weeks
|
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density.
Units: arbitrary units
|
Change from Baseline skin collagen density at 4 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The change of self-assessment skin condition
Periodo de tiempo: Change from Baseline skin condition at 4 weeks
|
Skin condition was evaluated using a 5-point Likert scale (0-4) to assess the severity of skin-related symptoms.
The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
|
Change from Baseline skin condition at 4 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chia-Hua Liang, Ph.D., Chia Nan University of Pharmacy & Science
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TMANH114-REC056
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .