Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Launched by PELAGE PHARMACEUTICALS, INC. · Apr 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PP405 for adults with androgenetic alopecia (AGA), commonly known as male or female pattern baldness. The trial has two parts: the first part will test the safety and how the body processes the treatment over 28 days. Participants will either receive PP405 or a placebo (a substance with no active treatment) without knowing which one they have. The second part will allow those who participated in the first part to continue receiving treatment for an additional three months, helping researchers gather more information on the long-term safety and effectiveness of PP405.

To be eligible for the trial, participants need to be between 18 and 55 years old, either male or female, and have specific types of hair loss associated with AGA. They must be able to provide written consent and agree to follow the study's rules. However, individuals with other types of hair loss, those using other hair loss treatments, or those with certain medical conditions will not be able to participate. If you join this trial, you can expect close monitoring and support throughout the study, helping us learn more about this potential new treatment for hair loss.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects aged 18 to 55 years.
• • 2. Able and willing to provide written informed consent.
• • 3. 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.
• • 4. Agree to comply with protocol procedures
• 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.