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Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA
The study is designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK following 28 days of administration.
Conditions:
🦠 Androgenetic Alopecia
🗓️ Study Start (Actual) 5 June 2024
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) February 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Encinitas, California, United States
📍 Thousand Oaks, California, United States
📍 Indianapolis, Indiana, United States
📍 New Brighton, Minnesota, United States
📍 Austin, Texas, United States
📍 Sugar Land, Texas, United States
📍 South Jordan, Utah, United States
📍 Norfolk, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Male or female subjects aged 18 to 55 years.
    • 2. Able and willing to provide written informed consent.
    • 3. 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.
    • 4. Agree to comply with protocol procedures

    Exclusion Criteria:

    • 1. Concomitant diagnosis of non-AGA forms of alopecia.
    • 2. Use of other hair loss treatments within periods specified in protocol.
    • 3. Use of excluded medications as specified in protocol.
    • 4. Diagnosis of other medical conditions as specified in protocol.
    • 5. 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.
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 April 2024
  • First Submitted that Met QC Criteria 26 April 2024
  • First Posted 1 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified June 2024
I'm interested ...!!