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- Ensayo clínico NCT03050086
Open Label Phase 2 Feasibility Study of BPX-04 Topical Minocycline Gel in Rosacea
An Open Label Phase 2 Feasibility Study to Assess the Safety and Efficacy of BPX-04 Minocycline Topical Gel in Treatment of Moderate to Severe Papulopustular Rosacea (BPX-01-C05)
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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California
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San Diego, California, Estados Unidos, 92123
- Study Center
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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:
- Male or female subjects ≥18 years of age at the time of consent.
- Subjects do not have any medical conditions, other than rosacea, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
- A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea (papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment (IGA) at Visit 1/Screening.
Female subjects of childbearing potential (including pre-puberty) are willing to use effective contraceptive method for at least 28 days before baseline (Day 0) and at least 28 days after the last study product administration or have a sterilized or same-sex partner for the duration of the study. Hormonal contraceptives must be on a stable dose for at least 12 weeks before baseline (Day 0). Subjects using low dose oral contraceptives must use a second form of birth control (e.g., barrier method such as condoms with spermicide).
Note: Female subjects of non-childbearing potential are defined as follows:
- Female subjects who have had surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation);
- Female subjects who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (refer to the central laboratory reference range for menopausal women) or cessation of menses for at least 24 months without FSH levels confirmed;
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline (Day 0).
- Treatment with hormonal therapy must be on a stable dose and frequency for at least 12 weeks before baseline (Day 0) and must remain stable throughout the study.
- Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or sunscreens must have used the same product brands/types for a minimum period of 14 days prior to baseline (Day 0), must agree not to change brand/type or frequency of use throughout the study and must agree not to use make-up, facial moisturizers, creams, lotions, cleansers and/or sunscreens on the clinic visit days before the visit.
- Subjects must be capable of giving informed consent and the written informed consent must be obtained prior to any study-related procedures.
Exclusion Criteria:
- Have a history of skin disease, presence of skin condition or excessive facial hair the PI believes would interfere with the study
- Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema
- Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial erythrosis other than rosacea
- Have ocular rosacea of a severity that requires systemic treatment
- Have a history of any adverse reaction to minocycline or other tetracycline class antibiotic
- Have a clinically significant chemistry or hematology value at baseline or have an ALT or AST at screening that is greater than or equal to 2x normal
- Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results
- Participated in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies
- Have used on the face an OTC topical medication for the treatment of rosacea within 4 weeks prior to baseline.
- Have used prescription topical (on the face) or oral antibiotics or corticosteroids within 4 weeks prior to baseline.
- Have had a facial procedure such as chemical peel, laser, microdermabrasion within 8 weeks prior to baseline
- Have received photodynamic therapy or phototherapy with blue or red light within 12 weeks prior to baseline
- Have used an oral retinoid within 6 months or a topical retinoid within 3 months prior to baseline
- Current drug or alcohol abuse
- Female subject who is breastfeeding, pregnant or who is planning a pregnancy during the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: BPX-04 1% Minocycline Topical Gel
once daily topical administration of 1% minocycline gel to the face
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once daily administration of topical minocycline gel to face
|
Experimental: BPX-04 2% Minocycline Topical Gel
once daily topical administration of 2% minocycline gel to the face
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once daily administration of topical minocycline gel to face
|
Comparador de placebos: BPX-01 Vehicle Topical Gel
once daily topical administration of vehicle gel to the face
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once daily administration of topical minocycline gel to face
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Investigator's Global Assessment
Periodo de tiempo: 12 weeks
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papules, pustules and erythema
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Lesion count
Periodo de tiempo: 12 weeks
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papules and pustules
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12 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- BPX-01-C05
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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 BPX-04 1% minocycline topical gel
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BioPharmX, Inc.TerminadoAcné comúnEstados Unidos
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BioPharmX, Inc.Terminado