Sicurezza, farmacocinetica ed efficacia di PP405 negli adulti con AGA
Uno studio di Fase 2a randomizzato, multicentrico, in doppio cieco, controllato dal veicolo per valutare la sicurezza, la farmacocinetica e l'efficacia di PP405 negli adulti con alopecia androgenetica
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
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California
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Encinitas, California, Stati Uniti, 92024
- California Dermatology & Clinical Research Institute
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Thousand Oaks, California, Stati Uniti, 91320
- Clinical Trials Research Institute
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Minnesota
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New Brighton, Minnesota, Stati Uniti, 55112
- Minnesota Clinical Study Center
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Texas
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Austin, Texas, Stati Uniti, 78759
- DermResearch
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Sugar Land, Texas, Stati Uniti, 77479
- Stride Clinical Research LLC
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Utah
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South Jordan, Utah, Stati Uniti, 84095
- Jordan Valley Dermatology Center
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Virginia
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Norfolk, Virginia, Stati Uniti, 23502
- Virginia Clinical Research, Inc.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
Altri nomi:
|
|
Comparatore 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
Altri nomi:
Vehicle = placebo topical gel
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Subjects With Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pharmacokinetics of PP405
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Christina Weng, Pelage Pharmaceuticals
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PP405-2001
Piano per i dati dei singoli partecipanti (IPD)
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