Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Pey… (NCT05777031) | Clinical Trial Compass
RecruitingPhase 4
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
United States22 participantsStarted 2023-10-02
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis.
✕. Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included.
✕. Previous history of priapism or penile fracture
✕. PD characterized by a ventral plaque
✕. Severe erectile dysfunction as characterized with an IIEF score ≤ 12