- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02650505
A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of LEO 43204 Gel and Gel Vehicle in Healthy Volunteers Using a Repeat Insult Patch Test Design
This is a randomized, single-center, controlled, within-subject comparison study assessing the sensitization potential of the investigational product, LEO 43204 gel under open conditions in healthy volunteers.
LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of the back. Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema and other signs of cutaneous irritation.
Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will enter the Challenge Phase, which consists of one 48-hour application to a naive site on the opposite side of the back. Observations at the naive site during Challenge and the patterns of reactivity during the Induction Phase will provide a basis for an interpretation of contact sensitization.
A total of 10 applications will be made over a period of approximately 6-8 weeks.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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Fair Lawn, New Jersey, Estados Unidos, 07410
- TKL Research Inc.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- Fitzpatrick skin types I-IV (due to lack of safety data for the investigational product in darker skin types);
- Complete a Medical Screening form as well as a Medical Personal History form;
Exclusion Criteria:
- Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- Are not willing to refrain from using topical/systemic analgesics for 72 hours prior to and during the study (daily use of 81 mg aspirin is acceptable and occasional use of acetaminophen will be permitted);
- Are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
- Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
- Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
- Have psoriasis and/or active atopic dermatitis/eczema;
- Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
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 |
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Experimental: LEO 43204
LEO 43204 will be applied topically to the skin under open conditions 10 times
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Comparador de placebos: LEO 43204 vehicle
LEO 43204 vehicle will be applied topically to the skin under open conditions 10 times
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
The determination of dermal sensitization will be based on LSRs and confirmed at a Rechallenge. If recurrence in Rechallenge is equivalent to or more severe than observed at challenge it will be considered indicative of a sensitization reaction.
Periodo de tiempo: 8 weeks
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LP0084-1230
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. .
Ensayos clínicos sobre León 43204
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LEO PharmaTerminadoQueratosis actínicaEstados Unidos
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LEO PharmaTerminado
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LEO PharmaTerminado
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LEO PharmaTerminado
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LEO PharmaTerminado
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LEO PharmaTerminado
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LEO PharmaTerminadoQueratosis actínicaEstados Unidos
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LEO PharmaTerminadoQueratosis actínicaEstados Unidos
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LEO PharmaTerminado
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LEO PharmaTerminado