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Completed

NCT Number: NCT06393452

Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Dermatology & Clinical Research Institute, Encinitas, California, United States

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About this study

Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PP405 0.05% Topical Gel

Drug

Medicated topical gel containing PP405 0.05%, applied once daily to the scalp

Other names: PP405 0.05%

Topical Vehicle Gel

Drug

Vehicle = placebo topical gel

Other names: Topical Placebo

Primary outcomes

  1. Percentage of Subjects With Adverse Events

    Time frame: 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

  2. Percentage of Subjects With Adverse Events

    Time frame: 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

  3. Change in Local Dermal Tolerability as Assessed by Subject and Investigator

    Time frame: Post-dose at day 28 of the randomized portion of the study

    Local skin reaction treatment emergent adverse events such as burning, pruritis, erythema

  4. Change in Local Dermal Tolerability as Assessed by Subject and Investigator

    Time frame: 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

  5. Change From Baseline in Blood Pressure

    Time frame: 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)

  6. Change From Baseline in Pulse Rate

    Time frame: 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)

  7. Change From Baseline in Temperature

    Time frame: 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)

  8. Change From Baseline in Respiratory Rate

    Time frame: 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)

  9. Change From Baseline in Weight

    Time frame: 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)

  10. Change From Baseline in Blood Pressure

    Time frame: 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)

  11. Change From Baseline in Pulse Rate

    Time frame: 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)

  12. Change From Baseline in Temperature

    Time frame: 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)

  13. Change From Baseline in Respiratory Rate

    Time frame: 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)

  14. Change From Baseline in Weight

    Time frame: 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)

  15. Change From Baseline in Mean Electrocardiogram Heart Rate

    Time frame: Baseline to day 28 of the randomized portion of the study

    Electrocardiogram mean heart rate was compared to baseline (day 28 minus baseline)

  16. Change From Baseline in Electrocardiogram (ECG) Results

    Time frame: Baseline to day 28 of the randomized portion of the study

    Electrocardiograms results were compared to baseline (day 28 minus baseline)

  17. Change From Baseline in Mean Electrocardiogram Heart Rate

    Time frame: 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)

  18. Change From Baseline in Electrocardiograms (ECGs)

    Time frame: 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)

  19. Abnormal Laboratory Values

    Time frame: 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)

  20. Abnormal Laboratory Values

    Time frame: 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)

Secondary outcomes

  1. Pharmacokinetics of PP405

    Time frame: Baseline to Day 28 of the randomized portion of the study

    To assess the concentration of PP405 in plasma at 2 hours (±10 minutes) post-dose on day 1, day 14, and day 28

  2. Pharmacokinetics of PP405

    Time frame: Baseline to Day 84 of the open label extension portion of the study

    To assess the concentration of PP405 in plasma at 2 hours (±10 minutes) post-dose on day 1, day 28, day 56, and day 84 of the open label extension

Sponsors and collaborators

Lead sponsor

Pelage Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 1, 2024
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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