Androgenetic AlopeciaPhase 2AWAKENINGNCT07907783
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
A Phase 2 study testing PP405 0.05% Topical Gel in people with Androgenetic Alopecia, run by Pelage Pharmaceuticals, Inc..
Trial summary
The study is designed to evaluate safety and efficacy of PP405 in adult female participants with androgenetic alopecia Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- PP405 0.05% Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female (assigned at birth) aged 18 to 65 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 Savin Scale stages I-3, I-4, II-1, or II-2
- Agree to comply with protocol procedures
Who cannot join
- Concomitant diagnosis of non-AGA forms of alopecia.
- Use of other hair loss treatments within periods specified in protocol.
- Use of excluded medications 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Multicenter, Double-Blind, Vehicle-Controlled, Phase 2 Study to Assess Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
The study is designed to evaluate safety and efficacy of PP405 in adult female participants with androgenetic alopecia
Read the detailed description
Participants will be randomized 1:1 to PP405 or vehicle and complete a 24 week double blinded treatment period.
- Conditions
- Androgenetic Alopecia
- Being tested
- PP405 0.05% Topical Gel, Vehicle Topical Gel
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PP405 0.05% Topical GelDrug
Also called PP405
Medicated topical gel containing PP405 0.05%
Vehicle Topical GelDrug
Also called Vehicle
Topical gel
| Study group | Role | What they receive |
|---|---|---|
| PP405 0.05% Topical Gel | Experimental | PP405 applied to the scalp from Day 1 to Week 24 Receives: Drug: PP405 0.05% Topical Gel |
| Vehicle Topical Gel | Placebo comparator | Vehicle applied to the scalp from Day 1 to Week 24 Receives: Drug: Vehicle Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in non-vellus target area hair count
Change from baseline in non-vellus target area hair count (nvTAHC)
Measured: Week 24
Secondary outcomes (5)
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 (ranges from -3 to +3)
Measured: 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
Measured: Week 24
Change from baseline in non-vellus target area hair count
Change from baseline in non-vellus target area hair count (nvTAHC)
Measured: 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 (ranges from -3 to +3)
Measured: 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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pelage Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Weng, MD, Study chair, Pelage Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907783
- Sponsor's protocol ID
- PP405-2003
- Acronym
- AWAKENING
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Vehicle-Controlled, Phase 2 Study to Assess Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07907783
- Acronym / sponsor ID
- AWAKENING / PP405-2003
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pelage Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| PP405 0.05% Topical Gel | Experimental | Drug: PP405 0.05% Topical GelPP405 applied to the scalp from Day 1 to Week 24 |
| Vehicle Topical Gel | Placebo comparator | Drug: Vehicle Topical GelVehicle applied to the scalp from Day 1 to Week 24 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female (assigned at birth) aged 18 to 65 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 Savin Scale stages I-3, I-4, II-1, or II-2
- Agree to comply with protocol procedures
Key exclusion criteria (5 listed)
- Concomitant diagnosis of non-AGA forms of alopecia.
- Use of other hair loss treatments within periods specified in protocol.
- Use of excluded medications 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PP405 0.05% Topical GelAlso: PP405Medicated topical gel containing PP405 0.05% | Drug | PP405 0.05% Topical Gel |
| Vehicle Topical GelAlso: VehicleTopical gel | Drug | Vehicle Topical Gel |
Primary outcome
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)
5 secondary outcomes
Change from baseline in the Participant Assessment of Scalp Coverage
Time frame: Week 24
≥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
Time frame: Week 12
Change from baseline in the Participant Assessment of Scalp Coverage
Time frame: Week 12
≥20% increase from baseline in non-vellus target area hair count
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Weng, MD study chair
Pelage Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PP405 0.05% Topical Gel in people with Androgenetic Alopecia, run by Pelage Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Sherman, VP of Clinical Operations ((213) 218-3830, clinicaltrials@pelagepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in non-vellus target area hair count (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.