Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Be able to provide written informed consent
• Have a diagnosis of PD with evidence of stable disease as determined by the investigator
• Patient must have palpable penile plaque
• Penile curvature deformity of \>30° to \<90°
• Agree to comply with all study related tests/procedures.
• Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature
Locations
United States
Florida
University of Miami
RECRUITING
Miami
University of Miami - Desai Sethi Urology Institute
RECRUITING
Miami
Contact Information
Primary
Thomas Masterson, MD
tmasterson@med.miami.edu
305-243-4562
Backup
Manuel Molina, MD
m.molina.leyba@miami.edu
3052434872
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 22
Treatments
Experimental: Collagenase Clostridium Histolyticum (CCH) Group
There will be 8 total treatments. These will follow the manufacturer protocol of 2 injections 24-72 hours apart (one cycle), followed by a 6-week break. This will total a maximum of 4 cycles.
Related Therapeutic Areas
Sponsors
Collaborators: Endo Pharmaceuticals
Leads: University of Miami