PP405 for Male Pattern Baldness

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

78 Participants Needed

Trial Summary

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 PP405 safe for treating male pattern baldness?

Minoxidil, a component of PP405, is generally safe for treating male pattern baldness, but it can cause scalp irritation, dryness, and itching. Finasteride, another component, may cause sexual dysfunction in men and reproductive issues, so it's important to discuss these potential side effects with a doctor. ^{1 2 3 4 5}

What is the purpose of this trial?

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. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.

Research Team

Christina Weng

Principal Investigator

Pelage Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States 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). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Interventions for Hirsutism. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Viable terminal scalp hair follicles constitute a necessary and sufficient biological end-organ that conditions clinical efficacy of finasteride in males with male pattern hair loss without implying reversal of miniaturized follicles. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Differences in reproductive toxicology between alopecia drugs: an analysis on adverse events among female and male cases. [2022]

5. Slovenia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 5% minoxidil topical foam in male pattern hair loss treatment and patient satisfaction. [2019]