- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07755865
A Clinical Trial to Evaluate the Effects of a Conditioning Mask on Hair Health, Breakage, Hydration, and Detangling
This study evaluates the effects of the Bounce Curl conditioning mask on hair health, breakage, hydration, and detangling. The trial is conducted as a single-arm, unblinded, virtual study in which all 40 enrolled participants use the test product twice per week over a one-week period.
Participants complete self-reported questionnaires at Baseline, after the first use, and at the end of Week 1. The primary objective is to examine the product's effects on hair health as reported by participants, while secondary objectives assess perceived changes in hair quality, hydration, breakage, detangling, softness, and frizz.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89101
- Citruslabs
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Be male or female.
- Be aged 18-50.
- Must have self-reported curly, coily, or wavy hair.
- In the past four weeks, has been experiencing issues regarding all of the following: hair health, hair breakage, hair hydration, and hair tangling.
- Anyone who washes and styles their hair at least once per week.
- Anyone who has been using the same hair care routine and products for at least one month prior to the study and is willing to maintain this for the study duration, i.e. shampoo and styling products.
- If taking any vitamins, minerals, or herbal supplements that target hair health, has been doing so for at least three months and is willing to maintain this routine for the duration of the study.
- Willing to avoid introducing any new products or any forms of medications or supplements that target hair health and appearance during the study period.
- Willing to avoid any chemical treatments to the hair during the study period, e.g. chemical straightening, hair extensions with chemical bonding, perms, and relaxers.
- Willing to avoid any form of protective styles (braids, singles, corn rows, etc) during the study period.
- Anyone willing to refrain from dying, highlighting, or cutting their hair for the study duration.
- Resides in the United States.
- Anyone who considers themselves in general good health.
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological, psychiatric disorders, and history of illness in the last three months.
- Anyone who has gotten a hair chemical treatment (e.g., keratin, dyeing, bleaching, perms) in the last month.
- Is currently undergoing or planning to undergo any significant medical procedures during the study period.
- Currently taking any prescription medication for hair loss.
- Currently has hair in any protective styles such as braids, cornrows, or singles.
- Anyone with any conditions that affect the hair or scalp (e.g., alopecia areata).
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone unwilling to follow the study protocol.
- Anyone with a history of substance abuse.
Plan de estudios
¿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: Bounce Curl Conditioning Mask
|
All 40 participants receive the Bounce Curl conditioning mask and apply it twice per week over one week.
After shampooing, participants apply a generous amount from ends to roots, leaving it on for 1 minute at the first application and 5 minutes at the second application.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Self-Reported Hair Health
Periodo de tiempo: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair health assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Self-Reported Hair Quality
Periodo de tiempo: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair quality assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Breakage
Periodo de tiempo: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair breakage assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Hydration
Periodo de tiempo: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair hydration assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Detangling
Periodo de tiempo: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair detangling assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Softness
Periodo de tiempo: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair softness assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
|
Change in Self-Reported Hair Frizz
Periodo de tiempo: Baseline, after first use, and Week 1
|
Mean change in participant-reported hair frizz assessed via self-reported questionnaire
|
Baseline, after first use, and Week 1
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 20779
- legacy-20779
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. .