PP405:n turvallisuus, farmakokinetiikka ja tehokkuus aikuisilla, joilla on AGA
Satunnaistettu, monikeskus, kaksoissokkoutettu, ajoneuvoohjattu, vaiheen 2a tutkimus PP405:n turvallisuuden, farmakokinetiikka ja tehon arvioimiseksi aikuisilla, joilla on androgeneettinen hiustenlähtö
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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California
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Encinitas, California, Yhdysvallat, 92024
- California Dermatology & Clinical Research Institute
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Thousand Oaks, California, Yhdysvallat, 91320
- Clinical Trials Research Institute
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Indiana
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Indianapolis, Indiana, Yhdysvallat, 46250
- Dawes Fretzin Clinical Research Group, LLC
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Minnesota
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New Brighton, Minnesota, Yhdysvallat, 55112
- Minnesota Clinical Study Center
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Texas
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Austin, Texas, Yhdysvallat, 78759
- DermResearch
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Sugar Land, Texas, Yhdysvallat, 77479
- Stride Clinical Research LLC
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Utah
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South Jordan, Utah, Yhdysvallat, 84095
- Jordan Valley Dermatology Center
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Virginia
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Norfolk, Virginia, Yhdysvallat, 23502
- Virginia Clinical Research, Inc.
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: 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
Muut nimet:
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Placebo Comparator: 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
Muut nimet:
Vehicle = placebo topical gel
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Percentage of Subjects With Adverse Events
Aikaikkuna: Baseline to Day 84 of the randomized portion of the study
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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
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|
Percentage of Subjects With Adverse Events
Aikaikkuna: 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
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Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Aikaikkuna: 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
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Change in Local Dermal Tolerability as Assessed by Subject and Investigator
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
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Change From Baseline in Electrocardiogram (ECG) Results
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
|
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Abnormal Laboratory Values
Aikaikkuna: Day 28 post baseline in the randomized portion of the study
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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
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Abnormal Laboratory Values
Aikaikkuna: Day 84 post baseline in the open label extension portion of the study
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Pharmacokinetics of PP405
Aikaikkuna: 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
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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
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|
Pharmacokinetics of PP405
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojen puheenjohtaja: Christina Weng, Pelage Pharmaceuticals
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- PP405-2001
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