PP405 0.05% topically applied gel for adult men with pattern hair loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind study compares PP405 0.05% gel to a vehicle for 24 weeks, then explores long-term safety through week 52 with an optional re-randomization step for the control group. Participants keep reporting hair-related outcomes and adverse events, while continuing the assigned treatment during the extension. The trial includes a 1:1 randomization at baseline and a second randomization at week 24 for the long-term safety portion. Primary endpoints focus on efficacy signals and tolerability in adult men meeting defined hair loss criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• AllerVie Clinical Research
  Birmingham, Alabama, United States Recruiting
• Cahaba Dermatology & Skin Health Center
  Birmingham, Alabama, United States Recruiting
• Johnson Dermatology
  Fort Smith, Arkansas, United States Recruiting
• Burke Pharmaceutical Research
  Hot Springs, Arkansas, United States Recruiting
• Ablon Skin Institute and Research Center
  Manhattan Beach, California, United States Recruiting
• Clinical Trials Research Institute
  Thousand Oaks, California, United States Recruiting

+13 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Lisa Sherman
• Email: clinicaltrials@pelagepharma.com
• Phone: 213-218-3830

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.