- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01922050
A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis
Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis
Part 1:
To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days
Part 2:
To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Edmonton, Alberta, Canadá, T5K 1X3
- Stratica Medical Inc.
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British Columbia
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Surrey, British Columbia, Canadá, V3R 6A7
- Guildford Dermatology Specialists
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New Brunswick
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Moncton, New Brunswick, Canadá, E1C 8X3
- Durondel C.P. Inc./Dermatology Clinic
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Ontario
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Barrie, Ontario, Canadá, L4M 6L2
- Ultranova Skincare
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Courtice, Ontario, Canadá, L1E 3C3
- Co-Medica Research Network Inc.
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Hamilton, Ontario, Canadá, L8N 1V6
- Dermatrials Research Incorporated
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London, Ontario, Canadá, N6A 3H7
- The Guenther Dermatology Research Centre
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Markham, Ontario, Canadá, L3P 1A8
- Lynderm Research Inc.
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Peterborough, Ontario, Canadá, K9J 1Z2
- Skin Centre For Dermatology
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Waterloo, Ontario, Canadá, N2J 1C4
- K. Papp Clinical Research
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Windsor, Ontario, Canadá, N8W 1E6
- XLR8 Medical Research
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Quebec
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Quebec City, Quebec, Canadá, G1V 4X7
- Centre de Recherche Dermatologique Du Quebec Metropolitain
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Arizona
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Phoenix, Arizona, Estados Unidos, 85018
- Omni Dermatology
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California
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Lomita, California, Estados Unidos, 90717
- Torrance Clinical Research Institute Inc.
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San Diego, California, Estados Unidos, 92121
- Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
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Florida
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Ormond Beach, Florida, Estados Unidos, 32174
- Leavitt Medical Associates of Florida
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Tampa, Florida, Estados Unidos, 33612
- Clinical Research Center, Morsani Center for Advanced Healthcare
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Indiana
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Evansville, Indiana, Estados Unidos, 47713
- Research Institute of Deaconess Clinic
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Evansville, Indiana, Estados Unidos, 47714
- Hudson Dermatology, LLC
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Maryland
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Rockville, Maryland, Estados Unidos, 20850
- DermAssociates, PC
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Michigan
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Bay City, Michigan, Estados Unidos, 48706
- Great Lakes Research Group, Inc.
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West Bloomfield, Michigan, Estados Unidos, 48322
- Henry Ford Medical Center, Dept. of Dermatology
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New Jersey
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Verona, New Jersey, Estados Unidos, 07044
- The Dermatology Group, P.C.
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, 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:
- Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures.
- Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face
- Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face or within a contiguous area of approximately 250 cm2 (40 in2) on the chest
- Subject at least 18 years of age.
Female subjects must be of either:
- Non-childbearing potential, i.e., have a confirmed clinical history of sterility (e.g., the subject is without a uterus or have tubal ligation), or,
- Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment.
- Female subjects of childbearing potential must use effective contraception throughout the study.
Exclusion Criteria:
Location of the treatment area within 5 cm (2 inches) of:
- an incompletely healed wound,
- a suspected basal or squamous cell carcinoma.
- Prior treatment with ingenol mebutate gel on the treatment area.
Lesions in the treatment areas that have:
- atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
- recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
- History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum, Rosacea), at the investigator's discretion.
- Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
- Any other disease or medical condition such as history or presence of cancer, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, or neurological disease or disorder, that, in the opinion of the investigator, makes the subject unsuitable to participate in the trial.
- Any abnormal laboratory or ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.
- Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications.
- Known sensitivity or allergy to any of the ingredients in the LEO 43204.
- Presence of acute sunburn within the treatment areas.
- Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
- Subjects previously randomised in the trial (Part 1 or 2).
- Female subjects who are breastfeeding.
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Part 1: LEO 43204 Formulation 1
Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
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Experimental: Part 1: LEO 43204 Formulation 2
Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
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Experimental: Part 2: LEO 43204 Formulation 1 Dose X
Double-Blind, Once-Daily, 2-Day Treatment
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Experimental: Part 2: LEO 43204 Formulation 1 Dose Y
Double-Blind, Once-Daily, 2-Day Treatment
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Experimental: Part 2: LEO 43204 Formulation 2 Dose XX
Double-Blind, Once-Daily, 2-Day Treatment
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Experimental: Part 2: LEO 43204 Formulation 2 Dose YY
Double-Blind, Once-Daily, 2-Day Treatment
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Comparador de placebos: Part 2: Placebo Formulation 1
Double-Blind, Once-Daily, 2-Day Treatment
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Comparador de placebos: Part 2: Placebo Formulation 2
Double-Blind, Once-Daily, 2-Day Treatment
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
Periodo de tiempo: From Day 1 up to and including Day 8
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The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT DLT was defined as one or more of the following 3 LSRs:
or two or more of the following five LSRs:
The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and 4 being the highest grade of severity. |
From Day 1 up to and including Day 8
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Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)
Periodo de tiempo: At Week 8
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At Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)
Periodo de tiempo: At Week 8
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Complete clearance was defined as a 100% reduction from baseline in AK count.
For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with complete clearance.
For treatment group 0.018 the table shows the percentage of mean number of participants with complete clearance in observed cases.
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At Week 8
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Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)
Periodo de tiempo: At Week 8
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Partial clearance was defined as at least 75% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with partial clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with partial clearance in observed cases. |
At Week 8
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gary Goldenberg, MD, Mount Sinai School of Medicine, Dermatology Faculty
Publicaciones y 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 (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
- LP0084-1013
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 LEO 43204 Formulation 1
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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 PharmaTerminadoEnfermedades del tejido conectivo | Enfermedades del Tejido de la PielAlemania
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LEO PharmaTerminado