Androgenetic Alopecia
Conditions
Brief summary
The study is designed to validate efficacy and long term safety of PP405.
Detailed description
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.
Interventions
Medicated topical gel containing PP405 0.05%
Topical gel
Sponsors
Pelage Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized (1:1) on Day 1 to one of the following two treatment sequences: 1. PP405 from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52 2. Vehicle from Day 1 to Week 24; then re-randomized 1:1 to either PP405 or vehicle from Week 24 to Week 52
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in non-vellus target area hair count | Week 24 | Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Participant Assessment of Scalp Coverage | Week 24 | Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage |
| ≥20% increase from baseline in non-vellus target area hair count | week 24 | Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count |
| Change from baseline in non-vellus target area hair count | Week 12 | Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex |
Contacts
CONTACTLisa Sherman
STUDY_CHAIRChristina Weng
Pelagepharmaceuticals
Outcome results
None listed