- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01493921
Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment
A Randomized, Double-Blind, Parallel, Vehicle-Controlled Phase III Trial to Assess the Efficacy and Safety of Topical SR-T100 Gel in the Treatment of Patients With Actinic Keratosis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Chiayi, Taiwán
- Chiayi Chang Gung Memorial Hospital
-
Kaohsiung, Taiwán
- Kaohsiung Chang Gung Memorial Hospital
-
Kaohsiung, Taiwán
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kaohsiung, Taiwán
- Kaohsiung Veterans General Hospital
-
Tainan, Taiwán
- National Cheng Kung University Hospital
-
Tainan, Taiwán
- Chi Mei Medical Center YongKang
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Male or female is 20 years of age or above and patient has at least two clinically visible, discrete, non hyperkeratotic, hypertrophic AK lesions located within a 25 cm squared contiguous or non contiguous treatment area including the arms, shoulder, chest, face and scalp. Patient has at least one histological confirmed actinic keratosis lesion of greater or equal to 4 mm in diameter within the selected treatment area.
Exclusion Criteria:
- Patient has any dermatological disease and condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area within 5cm distances from treatment area.
- Patient had used the following treatments within 4 weeks prior to the study treatment initiation as immunomodulators or immunosuppressive therapy,interferon and cytotoxic drugs.
- Patient treated with topical 5 FU, diclofenac gel, imiquimod, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation.
- Patient had received any of the following treatments on the treatment area in 6 months before study treatment initiation begins, such as psoralen plus UVA therapy, UVB therapy, laser abrasion, dermabrasion chemical peel.
- Patient is known to be hypersensitive to the study medication.
- Female who is pregnant, breast fed or considers of becoming pregnant while on the study.
- Patient had used of any investigational drug within the past 30 days before enrollment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: SR-T100 gel
Patient group receiving medication SR-T100 gel with active ingredient under investigation, enrolled subjects randomly assigned to this group to accurately depict statistical significance of the measured outcome.
|
Patient will be instructed to self-apply approximately 0.3~0.5g of SR-T100 gel on 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
|
Comparador activo: Vehicle gel
Patients given placebo with non-SR-T100 ingredients as they are being administered to patients, subjects are under random assignments from patient pool to depict statistically significant outcome measurement.
|
Patient wil be instructed to self-apply approximately 0.3~0.5g of vehicle gel (without active ingredient)per total of 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Comparison of SR-T100 gel effect with those of vehicle gel (Placebo) on efficacy and tolerability in patients with actinic keratosis
Periodo de tiempo: 24 weeks
|
The primary objective is to compare the complete clearance rate between treatment groups at 8 weeks after the completion of 16 weeks study treatment.
The primary efficacy endpoint is to evaluate the complete clearance rate at 8 weeks after the completion of 16 weeks study treatment between treatment groups.
The complete clearance is defined as the absence of visible or palpable AK lesions in the treatment area
|
24 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluation of efficacy and tolerability of SR-T100 gel in AK treatment
Periodo de tiempo: 24 weeks
|
SR-T100 clinical application in Actinic Keratosis treatment as direct proportional relationship to lesion size reduction, complete & partial clearance defined consequently as 100% & ≧75% reduction, coordinated toxicity & bio-safety reports supplements additional case study basis & foundation.
|
24 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GESRTAKA
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 SR-T100 gel
-
G&E Herbal Biotechnology Co., LTDTerminadoQueratosis actínica | Enfermedad de BowenTaiwán
-
G&E Herbal Biotechnology Co., LTDTerminadoVerrugas genitales | Condilomas acuminados | Condiloma acuminado | Verrugas venéreasTaiwán
-
G&E Herbal Biotechnology Co., LTDTerminadoQueratosis actínicaEstados Unidos
-
G&E Herbal Biotechnology Co., LTDSuspendido
-
G&E Herbal Biotechnology Co., LTDTerminadoQueratosis actínicaTaiwán
-
National Cheng-Kung University HospitalG&E Herbal Biotechnology Co., LTDTerminadoVerrugas genitales | Neoplasia Intraepitelial VulvarTaiwán
-
G&E Herbal Biotechnology Co., LTDTerminadoQueratosis actínicaTaiwán
-
University of Alabama at BirminghamAún no reclutando
-
PfizerTerminado
-
Stingray TherapeuticsReclutamientoTumor Sólido Avanzado/MetastásicoAustralia