Seguridad, farmacocinética y eficacia de PP405 en adultos con AGA
Un estudio de fase 2a aleatorizado, multicéntrico, doble ciego y controlado por vehículo para evaluar la seguridad, farmacocinética y eficacia del PP405 en adultos con alopecia androgenética
The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Encinitas, California, Estados Unidos, 92024
- California Dermatology & Clinical Research Institute
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Thousand Oaks, California, Estados Unidos, 91320
- Clinical Trials Research Institute
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Minnesota
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New Brighton, Minnesota, Estados Unidos, 55112
- Minnesota Clinical Study Center
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Texas
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Austin, Texas, Estados Unidos, 78759
- DermResearch
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Sugar Land, Texas, Estados Unidos, 77479
- Stride Clinical Research LLC
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Utah
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South Jordan, Utah, Estados Unidos, 84095
- Jordan Valley Dermatology Center
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
- Virginia Clinical Research, 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:
- Male or female subjects aged 18 to 55 years.
- Able and willing to provide written informed consent.
- Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
- Agree to comply with protocol procedures
Exclusion Criteria:
- Concomitant diagnosis of non-AGA forms of alopecia.
- Use of other hair loss treatments within periods specified in protocol.
- Use of excluded medications as specified in protocol.
- Diagnosis of other medical conditions as specified in protocol.
- Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: PP405 0.05% Topical Gel
PP405 0.05% Topical Gel applied once daily for 28 days. |
Medicated topical gel containing PP405 0.05%, applied once daily to the scalp
Otros nombres:
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|
Comparador de placebos: Topical Vehicle Gel, then PP405 0.05% Topical Gel
Topical Placebo Gel applied once daily for 28 days. Following the initial treatment and follow-up period through day 84, eligible subjects crossed over to apply PP405 0.05% topical gel for 84 days in an open-labeled extension. |
Medicated topical gel containing PP405 0.05%, applied once daily to the scalp
Otros nombres:
Vehicle = placebo topical gel
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Subjects With Adverse Events
Periodo de tiempo: Baseline to Day 84 of the randomized portion of the study
|
An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase |
Baseline to Day 84 of the randomized portion of the study
|
|
Percentage of Subjects With Adverse Events
Periodo de tiempo: Baseline to Day 84 of the open label extension portion of the study
|
An adverse event that was not present when the active phase of the study began and was not a chronic condition that was part of the subject's medical history; or, it was present at the start of the active phase of the study or as part of the subject's medical history, but the severity or frequency increased during the active phase |
Baseline to Day 84 of the open label extension portion of the study
|
|
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Periodo de tiempo: Post-dose at day 28 of the randomized portion of the study
|
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema |
Post-dose at day 28 of the randomized portion of the study
|
|
Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Periodo de tiempo: Post-dose at day 84 of the open label extension portion of the study
|
Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema |
Post-dose at day 84 of the open label extension portion of the study
|
|
Change From Baseline in Blood Pressure
Periodo de tiempo: Baseline to Day 84 of the randomized portion of the study
|
Change from baseline in blood pressure in the safety analysis population (day 84 minus baseline) |
Baseline to Day 84 of the randomized portion of the study
|
|
Change From Baseline in Pulse Rate
Periodo de tiempo: Baseline to Day 84 of the randomized portion of the study
|
Change from baseline in pulse rate in the safety analysis population (day 84 minus baseline) |
Baseline to Day 84 of the randomized portion of the study
|
|
Change From Baseline in Temperature
Periodo de tiempo: Baseline to Day 84 of the randomized portion of the study
|
Change from baseline in temperature in the safety analysis population (day 84 minus baseline) |
Baseline to Day 84 of the randomized portion of the study
|
|
Change From Baseline in Respiratory Rate
Periodo de tiempo: Baseline to Day 84 of the randomized portion of the study
|
Change from baseline in respiratory rate in the safety analysis population (day 84 minus baseline) |
Baseline to Day 84 of the randomized portion of the study
|
|
Change From Baseline in Weight
Periodo de tiempo: Baseline to Day 84 of the randomized portion of the study
|
Change from baseline in weight in the safety analysis population (day 84 minus baseline) |
Baseline to Day 84 of the randomized portion of the study
|
|
Change From Baseline in Blood Pressure
Periodo de tiempo: Baseline to Day 84 of the open label extension portion of the study
|
Change from baseline in blood pressure in the safety analysis population (open label extension day 84 minus open label extension baseline) |
Baseline to Day 84 of the open label extension portion of the study
|
|
Change From Baseline in Pulse Rate
Periodo de tiempo: Baseline to Day 84 of the open label extension portion of the study
|
Change from baseline in pulse rate in the safety analysis population (open label extension day 84 minus open label extension baseline) |
Baseline to Day 84 of the open label extension portion of the study
|
|
Change From Baseline in Temperature
Periodo de tiempo: Baseline to Day 84 of the open label extension portion of the study
|
Change from baseline in temperature in the safety analysis population (open label extension day 84 minus open label extension baseline) |
Baseline to Day 84 of the open label extension portion of the study
|
|
Change From Baseline in Respiratory Rate
Periodo de tiempo: Baseline to Day 84 of the open label extension portion of the study
|
Change from baseline in respiratory rate in the safety analysis population (open label extension day 84 minus open label extension baseline) |
Baseline to Day 84 of the open label extension portion of the study
|
|
Change From Baseline in Weight
Periodo de tiempo: Baseline to Day 84 of the open label extension portion of the study
|
Change from baseline in weight in the safety analysis population (open label extension day 84 minus open label extension baseline) |
Baseline to Day 84 of the open label extension portion of the study
|
|
Change From Baseline in Mean Electrocardiogram Heart Rate
Periodo de tiempo: Baseline to day 28 of the randomized portion of the study
|
Electrocardiogram mean heart rate was compared to baseline (day 28 minus baseline) |
Baseline to day 28 of the randomized portion of the study
|
|
Change From Baseline in Electrocardiogram (ECG) Results
Periodo de tiempo: Baseline to day 28 of the randomized portion of the study
|
Electrocardiograms results were compared to baseline (day 28 minus baseline) |
Baseline to day 28 of the randomized portion of the study
|
|
Change From Baseline in Mean Electrocardiogram Heart Rate
Periodo de tiempo: Baseline to day 84 of the open label extension portion of the study
|
Mean Electrocardiogram Heart Rate was compared to baseline of the open label extension study (day 84 minus baseline) |
Baseline to day 84 of the open label extension portion of the study
|
|
Change From Baseline in Electrocardiograms (ECGs)
Periodo de tiempo: Baseline to day 84 of the open label extension portion of the study
|
Electrocardiograms results were compared to baseline of the open label extension study (day 84 minus baseline) |
Baseline to day 84 of the open label extension portion of the study
|
|
Abnormal Laboratory Values
Periodo de tiempo: Day 28 post baseline in the randomized portion of the study
|
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high) |
Day 28 post baseline in the randomized portion of the study
|
|
Abnormal Laboratory Values
Periodo de tiempo: Day 84 post baseline in the open label extension portion of the study
|
Chemistry and hematology laboratory values were recorded as normal or abnormal (low or high) |
Day 84 post baseline in the open label extension portion of the study
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pharmacokinetics of PP405
Periodo de tiempo: Baseline to Day 28 of the randomized portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28
|
To assess the concentration of PP405 in plasma |
Baseline to Day 28 of the randomized portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28
|
|
Pharmacokinetics of PP405
Periodo de tiempo: Baseline to Day 84 of the open label extension portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84
|
To assess the concentration of PP405 in plasma |
Baseline to Day 84 of the open label extension portion of the study, assessed at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Christina Weng, Pelage Pharmaceuticals
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
- PP405-2001
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.
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