A Phase 2/3 interventional study of PP405 0.05% Topical Gel and Vehicle Topical Gel in Androgenetic Alopecia, sponsored by Pelage Pharmaceuticals, Inc.. Recruiting at 63 sites in 2 countries. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Pelage Pharmaceuticals, Inc. · Phase 2/3, Interventional, and Treatment
The study is designed to validate efficacy and long term safety of PP405.
Participants will initially be randomized 1:1 to PP405 or vehicle and complete a 24 week double blinded treatment period. At Week 24, the PP405 group will continue PP405 treatment, and the vehicle group will be re-randomized 1:1 to PP405 or vehicle for the double-blind long term safety extension period through study week 52.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's planned enrollment of 600 is above the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Pelage Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PP405 applied to the scalp from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52.
Drug: PP405 0.05% Topical Gel
Vehicle applied to the scalp from Day 1 to Week 24; then re-randomized 1:1 to receive either PP405 or vehicle QD from Week 24 to Week 52
Drug: PP405 0.05% Topical Gel · Drug: Vehicle Topical Gel
Medicated topical gel containing PP405 0.05%
Also known as: PP405
Topical gel
Also known as: Vehicle
Change from baseline in non-vellus target area hair count
Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex
Time frame: Week 24
Change from baseline in the Participant Assessment of Scalp Coverage
Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage
Time frame: Week 24
≥20% increase from baseline in non-vellus target area hair count
Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count
Time frame: week 24
Change from baseline in non-vellus target area hair count
Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex
Time frame: Week 12
Change from baseline in the Participant Assessment of Scalp Coverage
Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage
Time frame: Week 12
≥20% increase from baseline in non-vellus target area hair count
Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count
Time frame: week 12
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: JXL-069
Pelage Pharmaceuticals, Inc.