Segurança, farmacocinética e eficácia do PP405 em adultos com AGA
Um estudo randomizado, multicêntrico, duplo-cego, controlado por veículo, de fase 2a para avaliar a segurança, farmacocinética e eficácia do PP405 em adultos com 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
California
-
Encinitas, California, Estados Unidos, 92024
- California Dermatology & Clinical Research Institute
-
Thousand Oaks, California, Estados Unidos, 91320
- Clinical Trials Research Institute
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46250
- Dawes Fretzin Clinical Research Group, LLC
-
-
Minnesota
-
New Brighton, Minnesota, Estados Unidos, 55112
- Minnesota Clinical Study Center
-
-
Texas
-
Austin, Texas, Estados Unidos, 78759
- DermResearch
-
Sugar Land, Texas, Estados Unidos, 77479
- Stride Clinical Research LLC
-
-
Utah
-
South Jordan, Utah, Estados Unidos, 84095
- Jordan Valley Dermatology Center
-
-
Virginia
-
Norfolk, Virginia, Estados Unidos, 23502
- Virginia Clinical Research, Inc.
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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
Outros nomes:
|
|
Comparador de Placebo: 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
Outros nomes:
Vehicle = placebo topical gel
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Subjects With Adverse Events
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pharmacokinetics of PP405
Prazo: 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
Prazo: 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
- Cadeira de estudo: Christina Weng, Pelage Pharmaceuticals
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PP405-2001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .