- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04531540
Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)
27 de octubre de 2020 actualizado por: Bayer
HT201321- Repeated Insult Patch Test With Modified Challenge
In this study researcher want to learn more about possible skin reactions such after repeated application of an antifungal cream containing Trolamine.
They are especially interested in skin irritations or allergic skin reactions.
The study plans to enroll about 225 female or male participants with the age 18 - 79 years.
The antifungal test cream will be applied on the back between the shoulder blades of the participants and covered by a special dressing patch.
This will be repeated 3 times a week for the first 3 weeks of this study applying the cream on the same area of the back.
At each visit the skin will be investigated for redness, dryness and other reactions.
After a rest period of two weeks the test cream will be applied on the same skin area as before and on a second new skin area nearby.
After 2 and 4 days the two skin areas will again be investigated for redness, dryness and other reactions.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
225
Fase
- Fase 3
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.
Ubicaciones de estudio
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New Jersey
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Fairfield, New Jersey, Estados Unidos, 07004
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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
18 años a 79 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects must have been aged 18 to 79 years, inclusive;
- Female subjects must have produced a negative urine pregnancy test prior to the initiation and also at the completion of the trial;
- Subjects must have been capable of understanding and following directions.
Exclusion Criteria:
- Subjects who were in ill health or taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
- Subjects who had any visible skin disease that might be confused with a skin reaction to the test material;
- Subjects who were participating in another clinical trial at this facility or any other facility;
- Subjects who used topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial;
- Subjects who had a history of adverse reactions to adhesive tape, cosmetics, OTC drugs or other personal care products;
- Subjects judged by the PI to be inappropriate for the trial;
- Female subjects who were pregnant as evidenced by a urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Repeated Insult Patch Test
During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications.
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system.
After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site.
The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application.
The test sites were evaluated using the Induction Phase scoring system.
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Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects
Periodo de tiempo: After 4 weeks
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Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
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After 4 weeks
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Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects
Periodo de tiempo: After 6 weeks
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Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
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After 6 weeks
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Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects
Periodo de tiempo: After 4 weeks
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Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
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After 4 weeks
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Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects
Periodo de tiempo: After 6 weeks
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Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
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After 6 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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)
9 de septiembre de 2013
Finalización primaria (Actual)
18 de octubre de 2013
Finalización del estudio (Actual)
18 de octubre de 2013
Fechas de registro del estudio
Enviado por primera vez
26 de agosto de 2020
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2020
Publicado por primera vez (Actual)
28 de agosto de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
27 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 18156
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing".
This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.
This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.
Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
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. .
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