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Topical Agent

PP405 for Male Pattern Baldness

Phase 2
Waitlist Available
Research Sponsored by Pelage Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
Male or female subjects aged 18 to 55 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 28

Summary

This trial aims to confirm the safety findings from a previous trial and to understand the safety and how the drug is processed in the body over a longer period after 28 days of taking it.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects are not listed but will include any adverse reactions observed during the use of PP405 compared with those who receive the placebo gel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man with moderate hair loss or a woman with slight to moderate hair thinning.
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in local dermal tolerability as assessed by subject and investigator
Percentage of subjects with treatment-related adverse events
Secondary study objectives
Pharmacokinetics of PP405

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PP405 0.05% Topical GelActive Control1 Intervention
0.05% Topical Gel applied once daily
Group II: PP405 Topical Vehicle GelPlacebo Group1 Intervention
Placebo Topical Gel applied once daily

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Who is running the clinical trial?

Pelage Pharmaceuticals, Inc.Lead Sponsor
Christina WengStudy ChairPelage Pharmaceuticals
~0 spots leftby Dec 2024
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