A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
27 de julio de 2017 actualizado por: Braintree Laboratories
A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
The objective of the study is to compare the safety and efficacy of multiple formulations of BLI1100 to a control group and placebo in treating patients with moderate-severe acne vulgaris.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
509
Fase
- Fase 2
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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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- BLI Research Site 27
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Mobile, Alabama, Estados Unidos, 36608
- BLI Research Site 24
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Arizona
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Tucson, Arizona, Estados Unidos, 85745
- BLI Research Site 51
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Arkansas
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Rogers, Arkansas, Estados Unidos, 72758
- BLI Research Site 40
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California
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Chula Vista, California, Estados Unidos, 91911
- BLI Research Site 57
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Costa Mesa, California, Estados Unidos, 92626
- BLI Research Site 56
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Encino, California, Estados Unidos, 91436
- BLI Research Site 18
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Fremont, California, Estados Unidos, 94538
- BLI Research Site 7
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Upland, California, Estados Unidos, 91786
- BLI Research Site 45
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Colorado
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Denver, Colorado, Estados Unidos, 80220
- BLI Research Site 41
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Wheat Ridge, Colorado, Estados Unidos, 80033
- BLI Research Site 39
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Florida
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Hialeah, Florida, Estados Unidos, 33012
- BLI Research Site 19
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Jupiter, Florida, Estados Unidos, 33458
- BLI Research Site 49
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Miami, Florida, Estados Unidos, 33126
- BLI Research Site 12
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Miami Lakes, Florida, Estados Unidos, 33016
- BLI Research Site 54
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Ormond Beach, Florida, Estados Unidos, 32174
- BLI Research Site 20
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Port Saint Lucie, Florida, Estados Unidos, 34984
- BLI Research Site 59
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Saint Petersburg, Florida, Estados Unidos, 33709
- BLI Research Site 15
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Tampa, Florida, Estados Unidos, 33607
- BLI Research Site 1
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Tampa, Florida, Estados Unidos, 33609
- BLI Research Site 29
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Wellington, Florida, Estados Unidos, 33414
- BLI Research Site 28
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West Palm Beach, Florida, Estados Unidos, 33406
- BLI Research Site 43
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Indiana
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Plainfield, Indiana, Estados Unidos, 46168
- BLI Research Site 11
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- BLI Research Site 33
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Massachusetts
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Beverly, Massachusetts, Estados Unidos, 01915
- BLI Research Site 34
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Quincy, Massachusetts, Estados Unidos, 02169
- BLI Research Site 42
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Michigan
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Fort Gratiot, Michigan, Estados Unidos, 48059
- BLI Research Site 37
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68114
- BLI Research Site 9
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Omaha, Nebraska, Estados Unidos, 68144
- BLI Research Site 47
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New Hampshire
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Newington, New Hampshire, Estados Unidos, 03801
- BLI Research Site 5
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New York
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Stony Brook, New York, Estados Unidos, 11790
- BLI Research Site 46
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North Carolina
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High Point, North Carolina, Estados Unidos, 27262
- BLI Research Site 50
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Wilmington, North Carolina, Estados Unidos, 28401
- BLI Research Site 52
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45255
- BLI Research Site 32
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Oklahoma
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Norman, Oklahoma, Estados Unidos, 73071
- BLI Research Site 55
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Oregon
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Gresham, Oregon, Estados Unidos, 97030
- BLI Research Site 4
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19103
- BLI Research Site 60
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Rhode Island
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Johnston, Rhode Island, Estados Unidos, 02919
- BLI Research Site 10
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Tennessee
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Goodlettsville, Tennessee, Estados Unidos, 37072
- BLI Research Site 53
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Murfreesboro, Tennessee, Estados Unidos, 37130
- BLI Research Site 58
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Nashville, Tennessee, Estados Unidos, 37203
- BLI Research Site 14
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Texas
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Beaumont, Texas, Estados Unidos, 77701
- BLI Research Site 30
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Bryan, Texas, Estados Unidos, 77802
- BLI Research Site 6
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Houston, Texas, Estados Unidos, 77056
- BLI Research Site 3
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New Braunfels, Texas, Estados Unidos, 78130
- BLI Research Site 8
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Pflugerville, Texas, Estados Unidos, 78660
- BLI Research Site 44
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San Antonio, Texas, Estados Unidos, 78249
- BLI Research Site 16
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Utah
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Salt Lake City, Utah, Estados Unidos, 84117
- BLI Research Site 21
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- BLI Research Site 26
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Washington
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Spokane, Washington, Estados Unidos, 99202
- BLI Research Site 25
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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
12 años a 45 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Males or females 12 to 45 years of age, inclusive, in good general health.
- Clinical diagnosis of facial acne vulgaris
Patients with an Investigator's Global Assessment severity score of at least 3 that meet the following lesion count criteria:
- A minimum of 20 but not more than 50 inflammatory lesions (including the nose)
- A minimum of 30 but not more than 100 non-inflammatory lesions on the face (including the nose)
- No nodules are allowed on the entire face.
- Each patient or parent/guardian will read and sign the consent form as required by IRB regulations. Patients under the age of 18, but of sufficient age to provide assent (as determined by IRB regulations), will complete an assent form.
- Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication.
- Treatment with estrogens, androgens, or anti-androgenic agents for a non-contraceptive indication must be stable for 6 months prior to the first dose of study product and remain unchanged during the study.
- Patients who are willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- Patients who are mentally competent in the Investigator's judgment, to provide informed consent/assent to participate in the study
Exclusion Criteria:
Patients who had been treated with:
- systemic retinoids during a 6-month period before Visit 1 or by systemic antibiotics during a 4-week period before Visit 1
- or by a topical treatment (eg, antibiotics, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid, dapsone) or systemic corticosteroids during a 2-week period before the first dose of study medication.
- History of hereditary angio-edema
- Pregnancy, lactation or patient, who is not practicing effective contraception.
- Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin.
- A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal insufficiency).
- Erythroderma, immunodeficiency disorders and Mycosis Fungoides
- History of Epilepsy or Parkinson's disease
- History of alcohol and/or drug abuse within 5 years of screening
- Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
- Any single facial skin condition assessment graded as "Severe" at Visit 1
- Using drugs known to be photosensitizers because of the possibility of increased phototoxicity.
- Refusal to cease using the following types of facial products: astringents, toners, abradants, facials, loofahs, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide (BPO), hydroquinone, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids .
- Using medications that are reported to exacerbate acne .
- Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, during the 4 weeks prior to Visit 1.
- Unwilling to avoid excessive swimming and sun exposure to include artificial UV light exposure (tanning beds).
- Patients using comedogenic makeup.
- Have a known hypersensitivity or previous allergic reaction to any of the components .
- Employees of the clinical research site or organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
- Have a member of the same household in this trial.
- Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
- Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
- Patients who withdraw consent before completion of Visit 1 procedures
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: BLI1100-1
Topical gel
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BLI1100-1 Topical gel
|
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Experimental: BLI1100-2
Topical gel
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BLI1100-2 Topical gel
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Experimental: BLI1100-3
Topical gel
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BLI1100-3 Topical gel
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Experimental: BLI1100-4
Topical gel
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BLI1100-4 Topical gel
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Comparador de placebos: Placebo
Topical gel
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Placebo - Topical gel
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Absolute change in total lesion count
Periodo de tiempo: 12 weeks
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12 weeks
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Treatment success based on Investigator Global Assessment
Periodo de tiempo: 12 weeks
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12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
1 de octubre de 2015
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
12 de noviembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
12 de noviembre de 2015
Publicado por primera vez (Estimar)
13 de noviembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BLI1100-203
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. .