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A Study Assessing GW870086's Potential to Cause Skin Thinning

18 de julio de 2017 actualizado por: GlaxoSmithKline

A Randomised, Double-blind (for GW870086), Placebo-controlled Study of Topical GW870086 Formulation to Explore the Potential for Skin Thinning in Healthy Adult Volunteers

This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream.

Descripción general del estudio

Descripción detallada

This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. The primary objective of this study is to assess the thickness of the skin using ultrasound. The secondary objectives are to assess skin thinning using a visual scale for skin atrophy and telangiectasia, safety and tolerability of GW870086 and to assess the pharmacokinetics of GW870086 administered as a cream for 42±2 days.

Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream. They will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream. Subjects will apply all 3 treatments once daily during the 42±2 day treatment period. However subjects who are randomised to receive the unblinded clobetasol propionate will only apply this once daily for a maximum of 21±2 days but will continue to dose with the other 2 treatments. If significant evidence of skin thinning is observed in any of the treatment arms (25% reduction in skin thickness measured using ultrasound) then application of this treatment will be discontinued. Three areas of approximately 5 x 5 cm on the arm will be identified and each treatment will be applied to the same area throughout the 42±2 day treatment period.

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

Fase

  • Fase 1

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

      • Berlin, Alemania, 10117
        • GSK Investigational Site

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 55 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • AST (Aspartate aminotransferase), ALT (Alanine aminotransferase), alkaline phosphatase and bilirubin ≤ 1.5xULN (Upper limit of normal)(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Healthy as determined by an experienced physician.
  • Male or female between 18 and 55 years of age inclusive.
  • A female subject is eligible to participate if she is of:

    • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the protocol contraception methods if they wish to continue their HRT during the study.

  • Male subjects with female partners of child-bearing potential must agree to use one of the protocol contraception methods.
  • BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
  • Capable of giving written informed consent.
  • Single QTc, QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

Exclusion Criteria:

  • Any sign of weak or fragile skin, striae, or similar, in the areas which will be evaluated.
  • Tattoos or body art on the upper arms.
  • Foreseeable intensive UV exposure during the study (solar or artificial). Subjects must not be exposed to direct sunlight or skin tanning devices (e.g. sunbed) for the duration of the study.
  • A positive pre-study test for Hepatitis B or Hepatitis C antibody within 3 months of screening.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
  • A positive pre-study drug/alcohol screen.
  • A positive test for HIV (Human Immunodeficiency Virus) antibody.
  • History of regular alcohol consumption within 6 months of the study.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • History of sensitivity to any of the study medications or components thereof.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • Subjects who are kept due to regulatory or juridical order in an institution.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: GW870086 0.2% & GW870086 2%
GW870086 0.2%, 2% & placebo each applied to an identified area for 42 days.
White to slightly coloured opaque cream
White to slightly coloured opaque cream
White to slightly coloured opaque cream
Experimental: GW870086 2% & Clobetasol Propionate
GW870086 2% & placebo applied to an identified area for 42 days, while Clobetasol Propionate is applied to an area for 21 days
White to slightly coloured opaque cream
White to slightly coloured opaque cream
White cream

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change from baseline in skin thickness using ultrasound between GW870086 (0.2% and 2%) versus placebo
Periodo de tiempo: Days; 1, 14, 21, 28, 42, 43
Days; 1, 14, 21, 28, 42, 43

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia
Periodo de tiempo: Days; 7, 14, 21, 28, 35, 42, 43
Days; 7, 14, 21, 28, 35, 42, 43
The assessment of safety parameters; adverse events, clinical laboratory tests, ECG, and vital signs
Periodo de tiempo: 6 weeks
6 weeks
Plasma concentrations of GW870086
Periodo de tiempo: Days 14 & 42
Days 14 & 42
Cmax of GW870086
Periodo de tiempo: Days 14 & 42
Days 14 & 42
Tmax of GW870086
Periodo de tiempo: Days 14 & 42
Days 14 & 42
AUC of GW870086
Periodo de tiempo: Days 14 & 42
Days 14 & 42

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)

14 de abril de 2011

Finalización primaria (Actual)

7 de julio de 2011

Finalización del estudio (Actual)

7 de julio de 2011

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2011

Publicado por primera vez (Estimar)

27 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

18 de julio de 2017

Última verificación

1 de julio de 2017

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Datos del estudio/Documentos

  1. Formulario de consentimiento informado
    Identificador de información: 113435
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plan de Análisis Estadístico
    Identificador de información: 113435
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulario de informe de caso anotado
    Identificador de información: 113435
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Especificación del conjunto de datos
    Identificador de información: 113435
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Conjunto de datos de participantes individuales
    Identificador de información: 113435
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocolo de estudio
    Identificador de información: 113435
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informe de estudio clínico
    Identificador de información: 113435
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register

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 Dermatitis Atópica

Ensayos clínicos sobre GW870086 0.2%

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