Androgenetic AlopeciaPhase 2/3AWAKENNCT07819435

Phase 2/3 Efficacy and Safety of PP405 in Adult Males

A Phase 2/3 study testing PP405 0.05% Topical Gel in people with Androgenetic Alopecia, run by Pelage Pharmaceuticals, Inc. at 63 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The study is designed to validate efficacy and long term safety of PP405. Read more about this study

Who is it for?: Ages 18 to 55 years, men 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: 600 participants
Where: 63 sitesin 2 countries
Study dates: 21 Sep 2026to Jun 2028
Phase: Phase 2/3
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 55 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

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 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.

Trial locations and contacts

63 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Lisa Sherman contact

213-218-3830

clinicaltrials@pelagepharma.com

Country

City, postcode or hospital

Sites recruiting now only

63 sites in 2 countries

United States57 sites, 57 recruiting

DelRicht Research (Experience Dermatology)
Atlanta, Georgia, 30329
Recruiting
DelRicht Research @LA Dermatology Associates
Baton Rouge, Louisiana, 70809
Recruiting
Great Lakes Research Group Inc.
Bay City, Michigan, 48706
Not yet recruiting
Bexley Dermatology Research/Dermatologists of Southwestern Ohio
Bexley, Ohio, 43209
Not yet recruiting
AllerVie Clinical Research
Birmingham, Alabama, 35209
Recruiting
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, 35244
Recruiting
Optima Research Boardman
Boardman, Ohio, 441512
Recruiting
Skin Care Research, LLC
Boca Raton, Florida, 33486
Recruiting
Brigham and Woman's Hospital
Boston, Massachusetts, 02115
Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Not yet recruiting
Equity Medical
Bowling Green, Kentucky, 42104
Not yet recruiting
DS Research of Southern Indiana, LLC
Clarksville, Indiana, 47129
Not yet recruiting
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Recruiting
Skin Research Institute, LLC
Coral Gables, Florida, 33146
Recruiting
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Recruiting
Cleaver Medical Group Dermatology, Inc
Dawsonville, Georgia, 30534
Not yet recruiting
Eurofins CRL Cosmetic LLC
Forest, Virginia, 24551
Recruiting
Johnson Dermatology
Fort Smith, Arkansas, 72916
Recruiting
First OC Dermatology Research, Inc.
Fountain Valley, California, 92708
Not yet recruiting
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Recruiting
Dermatology and Laser Surgery Center
Houston, Texas, 77002
Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Recruiting
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37909
Recruiting
DS Research of Kentucky, LLC
Louisville, Kentucky, 40241
Not yet recruiting
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
Recruiting
Dermatologists of Southwest Ohio, LLC
Mason, Ohio, 45040
Not yet recruiting
Ada West Research
Meridian, Idaho, 83646
Not yet recruiting
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
Not yet recruiting
DelRicht Research @Mt Pleasant Dermatology
Mt. Pleasant, South Carolina, 29464
Recruiting
International Clinical Research
Murfreesboro, Tennessee, 37130
Not yet recruiting
AMR Clinical - Myrtle Beach
Myrtle Beach, South Carolina, 29588
Recruiting
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Recruiting
The Skin Center Dermatology Group
New City, New York, 10956
Not yet recruiting
DelRicht Research
New Orleans, Louisiana, 70115
Recruiting
Marc Avram, MD Office
New York, New York, 10021
Not yet recruiting
Equity Medical, LLC
New York, New York, 10023
Recruiting
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Not yet recruiting
Quest Dermatology Research
Northridge, California, 91324
Not yet recruiting
Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Recruiting
NW Dermatology Institute
Portland, Oregon, 97210
Not yet recruiting
DelRicht Research @Lockhart Matter Dermatology
Prosper, Texas, 75078
Not yet recruiting
Northwest Arkansas Clinical Trials Center/Hull Dermatology P.A.
Rogers, Arkansas, 72758
Not yet recruiting
Integrative Skin Science and Research
Sacramento, California, 95815
Not yet recruiting
Progressive Clinical Research, PA
San Antonio, Texas, 78213
Recruiting
Texas Dermatology & Laser Specialists
San Antonio, Texas, 78218
Recruiting
TCR Medical Corporation
San Diego, California, 92123
Not yet recruiting
Delricht Research (Harpeth Valley Dermatology)
Smyrna, Tennessee, 37167
Recruiting
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Recruiting
Stryde Consulting, LLC
Southlake, Texas, 76092
Not yet recruiting
MOORE Clinical Research, Inc.
Tampa, Florida, 33607
Recruiting
Equity Medical
The Bronx, New York, 10455
Recruiting
Clinical Trials Research Institute
Thousand Oaks, California, 91230
Recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
Recruiting
Research Institute of the Southeast
West Palm Beach, Florida, 33401
Recruiting
DelRicht Research (Town Center Dermatology)
Wildwood, Missouri, 63040
Recruiting
WDC Cosmetic and Research, PLLC
Wilmington, North Carolina, 28405
Not yet recruiting
Vitality Clinical Trials LLC
Woodbury, New York, 11797
Recruiting

Other trials in United States

Canada6 sites, 6 recruiting

Medicor Research, Inc
Greater Sudbury, Ontario, P3C1X3
Not yet recruiting
Innovaderm Research Inc
Montreal, Quebec, H2X2V1
Recruiting
The Centre for Clinical Trials
Oakville, Ontario, L6J7W5
Not yet recruiting
Skin Centre for Dermatology
Peterborough, Ontario, K9J5K2
Not yet recruiting
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, L4B1L1
Not yet recruiting
Centre de Recherche Saint-Louis
Sherbrooke, Quebec, J1G1X9
Not yet recruiting

Other trials in Canada

About this study

Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2/3 Study to Assess Efficacy and Long-Term Safety of PP405 in Adult Males With Androgenetic Alopecia

The study is designed to validate efficacy and long term safety of PP405.

Read the 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.

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 groups in NCT07819435
Study group	Role	What they receive
PP405 0.05% Topical Gel	Experimental	PP405 applied to the scalp from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52. Receives: Drug: PP405 0.05% Topical Gel
Vehicle Topical Gel	Placebo comparator	Vehicle applied to the scalp from Day 1 to Week 24; then re-randomized 1:1 to receive either PP405 or vehicle QD from Week 24 to Week 52 Receives: Drug: PP405 0.05% Topical Gel; 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) at the vertex
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
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) at the vertex
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
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.

21 Sep 2026Jun 2028

First posted15 Sep 2026
Study start21 Sep 2026
Primary completionDec 2027 (estimated)
Study completionJun 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 2/3
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 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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07819435
Sponsor's protocol ID: PP405-2002
Acronym: AWAKEN
Status last verified: Sep 2026
First submitted: 9 Sep 2026
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Lisa Sherman

213-218-3830

clinicaltrials@pelagepharma.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

All Androgenetic Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2/3 Study to Assess Efficacy and Long-Term Safety of PP405 in Adult Males With Androgenetic Alopecia
ClinicalTrials.gov ID: NCT07819435
Acronym / sponsor ID: AWAKEN / PP405-2002
Conditions: Androgenetic Alopecia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: Pelage Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 21 Sep 2026 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Jun 2028 (estimated)
First posted: 15 Sep 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 validate efficacy and long term safety of PP405.

Detailed description

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 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

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; then continuing PP405 from Week 24 to Week 52.
Vehicle Topical Gel	Placebo comparator	Drug: PP405 0.05% Topical Gel, Drug: Vehicle Topical GelVehicle applied to the scalp from Day 1 to Week 24; then re-randomized 1:1 to receive either PP405 or vehicle QD from Week 24 to Week 52

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

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 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.

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 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) at the vertex

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 28 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Androgenetic Alopecia

Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia

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.

Lisa Sherman contact

213-218-3830

clinicaltrials@pelagepharma.com

Christina Weng study chair

Pelagepharmaceuticals

63 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PP405 0.05% Topical Gel in people with Androgenetic Alopecia, run by Pelage Pharmaceuticals, Inc. at 63 sites in 2 countries.

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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 (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?

On the ClinicalTrials.gov record for NCT07819435.

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 28 Oct 2026.