NCT07819435 · Pelage Pharmaceuticals, Inc.
Phase 2/3 Efficacy and Safety of PP405 in Adult Males
(AWAKEN)
What this study is about
The study is designed to validate effectiveness and long term safety of PP405.
View original scientific description
The study is designed to validate efficacy and long term safety of PP405.
Interventions
DRUG
PP405 0.05% Topical Gel
Medicated topical gel containing PP405 0.05%
DRUG
Vehicle Topical Gel
Topical gel
Primary outcome measures
Change from baseline in non-vellus target area hair count
Time frame: Week 24
Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males (assigned at birth) aged 18 to 55 years, inclusive at time of consent.
- Able and willing to provide written informed consent
- Must have been experiencing Androgenetic Alopecia (AGA) for at least 6 months prior to screening.
- Have a modified Norwood-Hamilton score of Type IV or Type V
- 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 and procedures 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.
Where
- Fort Smith, Arkansas
- Hot Springs, Arkansas
- Manhattan Beach, California
- Thousand Oaks, California
- Coral Gables, Florida
- Tampa, Florida
- Atlanta, Georgia
- Indianapolis, Indiana
- Plainfield, Indiana
- Baton Rouge, Louisiana
- New Brighton, Minnesota
- Wildwood, Missouri
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations