- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07695805
Evaluation of the Effect of Combined Use of Cosmetic Products for Dry and Itchy Skin.
Confirmation in Human Subjects of a Cosmetic Product Efficacy After Application in the Body Under Normal Conditions of Use.
The goal of this study is to learn if combined use of shower oleogel and body lotion works to improve skin itching and dryness in adults. It will also learn about its safety. The main question it aims to answer is:
• Does the products use improves skin hydration and itching? Researchers will compare shower oleogel and body lotion to a commercially available shower gel and the body lotion to see if the combined use is more efficient than use of body lotion alone.
Participants will:
- Use assigned products every day for 1 month
- Visit the CRO for checkups and tests on established schedule
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Contreiras
- Número de teléfono: +34 93 101 66 95
- Correo electrónico: geral@phdtrials.com
Ubicaciones de estudio
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Lisbon District
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Lisbon, Lisbon District, Portugal, 1750-182
- PhD Trials
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Contacto:
- Contreiras
- Número de teléfono: +34 93 101 66 95
- Correo electrónico: geral@phdtrials.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age: 18-70 years old
- Gender: both
- Sensitive skin and 30% to 50% with atopic tendency (scored 8-12)
- With dry or very dry skin on the body
- With presence of itching due to different origins: contact/friction with fabrics, hard water, atopic tendency, dry skin, etc.
Exclusion Criteria:
- cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions (pigmentation troubles, scar elements, over-developed pilosity, ephelides and naevi in too great quantity, sunburn),
- allergy or reactivity to products of the same category than the tested one,
- with history of malignant melanomas (Dubreullh melanosis…)
- unbalanced hormonal treatment,
- forecast of initiation of an hormonal treatment or change of the usual hormonal treatment during the study or 3 months before the starting of the study,
- forecast of intensive sun or UVA exposure (UV lamps) during the test period,
- breast-feeding or pregnancy,
- treatment with Vitamin A acid or its derivatives stopped less than 3 months before the beginning of the study,
- treatment with anti-stretch, firming, slimming or anti-cellulite products stopped less than 3 months before the beginning of the study,
- diet stopped less than 3 months before the beginning of the study,
- drugs likely to produce an increase or reduction in body weight,
- under anti-cellulite treatment: mesotherapy, electrotherapy, ionisation, ultrasonotherapy, relaxation, acupuncture, hydrotherapy, lymphatic drainage, massage, sauna,…,
- neither antibiotic, anti-allergic, anti-inflammatory treatment nor treatment with patent medicines containing Vitamin A acid or its derivatives before and during the study (if therapeutic requirement: exclusion foreseen),
- systemic disorders: Cardiovascular, pulmonary, digestive, neurologic, psychiatric, genital, urinary, haematological, endocrine
- individuals who have undergone a bilateral mastectomy with lymph node removal, a unilateral mastectomy with lymph node removal within the last year, or a bilateral axillary lymph node removal,
- individuals with a history of immune deficiency or auto-immune disease, treated for malignancy within 6 months prior to enrollment or who are currently under treatment for asthma or diabetes,
- forecast of vaccination during the test period or last vaccination within 3 weeks before the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: shower oleogel and body lotion
shower oleogel and body lotion will be used daily for 28 days
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Daily use of shower oleogel and body lotion for 28 days
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Comparador activo: shower gel and body lotion
shower gel and body lotion will be used daily for 28 days
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Daily use of shower gel and body lotion
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change from Baseline in the rate of skin hydration (capacitance measured by Corneometer) at 4 weeks
Periodo de tiempo: From enrollment to the end of the study at 4 weeks
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From enrollment to the end of the study at 4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change from Baseline in the rate of skin barrier function (TEWL evaluated by Tewameter) at 4 weeks.
Periodo de tiempo: From enrollment to the end of the study at 4 weeks
|
From enrollment to the end of the study at 4 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Perdo Contreiras, PhD Trials
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- PhDES2851B
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
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