PP405 for Male Pattern Baldness

Not currently recruiting at 7 trial locations

Overseen By Lisa Sherman

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Pelage Pharmaceuticals, Inc.

Disqualifiers: Non-AGA alopecia, other hair treatments, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical gel, PP405, to determine its safety and effectiveness in treating male pattern baldness. It seeks to confirm safety findings from a previous trial and to gather more information about the gel's long-term effects. Participants will receive either the active gel or a placebo for 28 days, with some continuing in an open-label phase for three months. Men with a specific pattern of hair loss (Norwood-Hamilton Type III-V) who have not recently used other hair loss treatments are suitable candidates for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that some medications are excluded as specified in the protocol. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that PP405 is likely to be safe for humans?

Research has shown that PP405, a gel applied to the scalp for male pattern baldness, is safe for humans. In a previous study, PP405 proved to be safe and effective without entering the body, meaning it remained on the scalp and reduced the risk of side effects elsewhere. Another study confirmed that PP405 met safety standards, with no major side effects reported.

The main ingredient, similar to minoxidil, is generally safe for treating hair loss. However, some people might experience mild side effects like scalp irritation or itching. These are common with topical treatments and are usually easy to manage.

Overall, evidence suggests that PP405 is safe for use on the scalp, making it a promising choice for those wanting to treat male pattern baldness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for male pattern baldness?

Researchers are excited about PP405 for male pattern baldness because it offers a novel approach with its 0.05% topical gel formulation. Unlike current treatments like minoxidil or finasteride, which typically work by stimulating hair growth through different pathways, PP405 is believed to operate via a unique mechanism that specifically targets the hair follicles in a new way. The convenience of a once-daily topical application, combined with the potential for fewer systemic side effects, makes PP405 an attractive alternative to existing oral or more complex application treatments.

What evidence suggests that PP405 might be an effective treatment for male pattern baldness?

Research has shown that PP405 0.05% topical gel, which participants in this trial may receive, might help treat male pattern baldness. In one study, 31% of participants experienced more than a 20% increase in hair density, suggesting that PP405 could aid in hair regrowth. Another study found an increase in a marker called Ki67, linked to hair growth, in hair follicles after using PP405. Additionally, PP405 led to noticeable hair growth within weeks of use. These findings strongly suggest that PP405 may be a promising option for those with male pattern baldness. ^{1 2 5 6 7}

Who Is on the Research Team?

Christina Weng

Principal Investigator

Pelage Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 55 with Alopecia Areata, general hair loss, or male pattern baldness. Men must have moderate baldness according to the Norwood-Hamilton scale, and women should have mild thinning as per the Savin scale. Participants need to agree to follow study rules.

Inclusion Criteria

I am a man with moderate hair loss or a woman with slight to moderate hair thinning.

I am willing and able to sign a consent form.

I agree to follow the study's rules and procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Randomized controlled portion focusing on safety and PK with 28 days of blinded treatment administration

4 weeks

Daily application

Open-label extension

Open-label extension to validate results of Part 1 with 3 months of treatment administration

12 weeks

Daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PP405

Trial Overview The trial tests a new topical gel called PP405 (0.05%) against a placebo gel without active medication. It aims to confirm safety from earlier trials and assess long-term effects after using it daily for 28 days.

How Is the Trial Designed?

Group I: PP405 0.05% Topical Gel - Open Label Extension Experimental Treatment 1 Intervention

0.05% Topical Gel applied once daily for subjects who crossover into the Open-label Extension

Group II: PP405 0.05% Topical Gel Active Control 1 Intervention

0.05% Topical Gel applied once daily

Group III: PP405 Topical Vehicle Gel Placebo Group 1 Intervention

Placebo Topical Gel applied once daily

Who Is Running the Clinical Trial?

Pelage Pharmaceuticals, Inc.

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

Cetosomal minoxidil 5% was found to be effective in treating androgenetic alopecia (AGA), with 52% of patients showing significant to excellent improvement after 16 weeks, compared to 68% in the combination group with finasteride.

The cetosomal formulation demonstrated good tolerability, with 64% of patients rating it as excellent, suggesting it may be a safer alternative to traditional alcoholic minoxidil solutions, which are often associated with adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness, Safety, and Tolerability of Cetosomal Minoxidil 5% Alone and a Fixed Drug Combination of Cetosomal Minoxidil 5% With Finasteride 0.1% in the Management of Androgenetic Alopecia (Inbilt Study). Kerure, A., Ghalla, M., Mahajan, S., et al.[2023]

Oral contraceptive pills (OCPs) are effective for treating mild hirsutism, while flutamide and spironolactone are recommended for more severe cases, indicating a range of treatment options based on severity.

Finasteride and gonadotropin-releasing analogues show inconsistent results, and metformin does not provide any benefit for hirsutism, highlighting the importance of choosing the right therapy for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for Hirsutism. van Zuuren, EJ., Fedorowicz, Z.[2018]

Citations

1. dermatologytimes.com dermatologytimes.com/view/pelage-s-pp405-demonstrates-efficacy-in-phase-2a-trial-for-androgenetic-alopecia

Pelage's PP405 Demonstrates Efficacy in Phase 2a Trial ... PP405 shows promise for hair regrowth in phase 2a trial, with 31% seeing >20% density increase; phase 3 studies are planned for 2026.

2. hermestclinic.com hermestclinic.com/pp405/

PP405 Hair Loss Treatment: Trials, Mechanism & Timeline Treatment: 0.05% PP405 topical solution applied once nightly for 7 days. Findings: Significant increase in Ki67 expression in hair follicles.

3. chemistry.ucla.edu chemistry.ucla.edu/news/faculty-in-the-news-michael-jung/

Faculty in the News – Michael Jung The Phase 1 trial evaluating PP405, a novel topical agent designed to treat androgenetic alopecia and other forms of hair loss, showed 0.05% PP ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06393452

Safety, Pharmacokinetics and Efficacy of PP405 in Adults ... The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK.

5. baumanmedical.com baumanmedical.com/pelage-pp405-stimulates-hair-follicle-stem-cells-via-mitochondria-in-phase-1-trial/

Pelage PP405 Stimulates Hair Follicle Stem Cells via ... Efficacy in Hair Growth: PP405 demonstrated statistically significant increases in terminal hair growth within weeks of topical application, ...

6. pelagepharma.com pelagepharma.com/

Pelage PP405 activates dormant hair follicle stem cells, restoring the natural regenerative capacity of the follicle and activating new hair growth in previously bald ...

7. withpower.com withpower.com/trial/phase-2-alopecia-areata-5-2024-eb7e5

PP405 for Male Pattern Baldness · Info for Participants Minoxidil, a component of PP405, is generally safe for treating male pattern baldness, but it can cause scalp irritation, dryness, and itching. Finasteride, ...