Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: Peyronie Disease; Genital Diseases, Male; Sexual Dysfunctions, Psychological

Treatments: Drug: Collagenase Clostridium Histolyticum (CCH)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05777031

20221234

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be able to provide written informed consent
2. Have a diagnosis of PD with evidence of stable disease as determined by the investigator
3. Patient must have palpable penile plaque
4. Penile curvature deformity of >30° to <90°
5. Agree to comply with all study related tests/procedures.
6. Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature

Exclusion criteria

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis.
2. Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included.
3. Previous history of priapism or penile fracture
4. PD characterized by a ventral plaque
5. Severe erectile dysfunction as characterized with an IIEF score ≤ 12
6. Hour-glass deformity
7. Unwilling to participate
8. Medically unfit for sexual intercourse as deemed by the principal investigator
9. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
10. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Collagenase Clostridium Histolyticum (CCH) Group

Experimental group

Description:

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.

Treatment:

Drug: Collagenase Clostridium Histolyticum (CCH)