Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia

A Randomized, Multicenter, Double-Blind, Vehicle-Controlled, Phase 2 Study to Assess Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07907783

Acronym

AWAKENING

Enrollment

200

Registered

2026-10-30

Start date

2026-11-01

Completion date

2028-03-01

Last updated

2026-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Brief summary

The study is designed to evaluate safety and efficacy of PP405 in adult female participants with androgenetic alopecia

Detailed description

Participants will be randomized 1:1 to PP405 or vehicle and complete a 24 week double blinded treatment period.

Interventions

DRUGPP405 0.05% Topical Gel

Medicated topical gel containing PP405 0.05%

DRUGVehicle Topical Gel

Topical gel

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 treatments: 1. PP405 from Day 1 to Week 24 2. Vehicle from Day 1 to Week 24

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Female (assigned at birth) aged 18 to 65 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 Savin Scale stages I-3, I-4, II-1, or II-2 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 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)

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)

Contacts

CONTACTLisa Sherman, VP of Clinical Operations

clinicaltrials@pelagepharma.com(213) 218-3830

STUDY_CHAIRChristina Weng, MD

Pelage Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 31, 2026