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

NCT05777031 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20221234
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of Treatment Related Adverse Events

  To determine number of treatment related adverse events. Safety will be evaluated via the incidence of adverse events as assessed by treating physician

  up to 6 months (post-intervention)

• Percent change of penile curvature in degrees.

  Treatment efficacy of CCH will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis.

  Baseline up to 6 months

Secondary Outcomes (2)

• Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).

  Baseline, 6 months.

• Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores

  Baseline, 6 months

Study Arms (1)

Collagenase Clostridium Histolyticum (CCH) Group

EXPERIMENTAL

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.

Drug: Collagenase Clostridium Histolyticum (CCH)

Interventions

Collagenase Clostridium Histolyticum (CCH) DRUG

Injection of intralesional CCH (0.58mg) to the penile plaque at the point of maximal curvature. Second injection of each cycle will be injected 2-3mm apart from the prior injection.

Also known as: Xiaflex

Collagenase Clostridium Histolyticum (CCH) Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Hour-glass deformity
• Unwilling to participate
• Medically unfit for sexual intercourse as deemed by the principal investigator
• Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
• 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.

Sponsors & Collaborators

• University of Miami: lead
• Endo Pharmaceuticals: collaborator

Study Sites (2)

University of Miami - Desai Sethi Urology Institute

Miami, Florida, 33136, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Penile Induration; Sexual Dysfunctions, Psychological; Genital Diseases, Male

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Thomas Masterson, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Masterson, MD

CONTACT

305-243-4562; tmasterson@med.miami.edu

Manuel Molina, MD

CONTACT

3052434872; m.molina.leyba@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (2)