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Recruiting
NCT07819435
Phase 2/3 Efficacy and Safety of PP405 in Adult Males
Conditions: Androgenetic Alopecia
Sex: Male
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 600
Sponsor: Pelage Pharmaceuticals, Inc.
Location: AllerVie Clinical Research Birmingham Alabama
Summary
The study is designed to validate efficacy and long term safety of PP405.
Eligibility Criteria
Inclusion Criteria:
1. Males (assigned at birth) aged 18 to 55 years, inclusive at time of consent.
2. Able and willing to provide written informed consent
3. Must have been experiencing Androgenetic Alopecia (AGA) for at least 6 months prior to screening.
4. Have a modified Norwood-Hamilton score of Type IV or Type V
5. 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 and procedures 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.
Source: ClinicalTrials.gov (NCT07819435). StuddyBuddy aggregates publicly available trial information.
