ClinicalTrials.gg
Not yet recruitingNCT07907783AWAKENINGUpdated Nov 6, 2026

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

A Phase 2 interventional study of PP405 0.05% Topical Gel and Vehicle Topical Gel in Androgenetic Alopecia, sponsored by Pelage Pharmaceuticals, Inc.. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Pelage Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Androgenetic Alopecia

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03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Female (assigned at birth) aged 18 to 65 years, inclusive at time of consent.
  2. Able and willing to provide written
  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

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.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    PP405 0.05% Topical Gel

    PP405 applied to the scalp from Day 1 to Week 24

    Drug: PP405 0.05% Topical Gel

  • Placebo comparator
    Vehicle Topical Gel

    Vehicle applied to the scalp from Day 1 to Week 24

    Drug: Vehicle Topical Gel

Interventions

  • Medicated topical gel containing PP405 0.05%

    Also known as: PP405

  • DrugVehicle Topical Gel

    Topical gel

    Also known as: Vehicle

06

What researchers measure

Primary outcomes

  1. Change from baseline in non-vellus target area hair count

    Change from baseline in non-vellus target area hair count (nvTAHC)

    Time frame: Week 24

Secondary outcomes

  1. 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)

    Time frame: Week 24

  2. ≥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

  3. Change from baseline in non-vellus target area hair count

    Change from baseline in non-vellus target area hair count (nvTAHC)

    Time frame: Week 12

  4. 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)

    Time frame: Week 12

  5. ≥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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Secondary outcomes
2 description edited
What changed in the outcomes
  • DescriptionChange from baseline in the Participant Assessment of Scalp Coverage: how it is measured was reworded
  • DescriptionChange from baseline in the Participant Assessment of Scalp Coverage#2: how it is measured was reworded
Nov 6, 2026
Registered
First appeared on the registry
Oct 30, 2026
Show all 2 updates
  1. Nov 6, 2026
    Secondary outcomes 2 description edited
    What changed in the outcomes
    • DescriptionChange from baseline in the Participant Assessment of Scalp Coverage: how it is measured was reworded
    • DescriptionChange from baseline in the Participant Assessment of Scalp Coverage#2: how it is measured was reworded
  2. Oct 30, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07907783
Lead sponsor
Pelage Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Oct 30, 2026
Start date
Nov 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Lisa Sherman, VP of Clinical Operations
Contact
clinicaltrials@pelagepharma.com
(213) 218-3830
Christina Weng, MD
study chair · Pelage Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: JXL-069

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