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

June 2, 2026 updated by: Manuel Molina Leyba, University of Miami

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33136
        • University of Miami - Desai Sethi Urology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Collagenase Clostridium Histolyticum (CCH)
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.
Other Names:
  • Xiaflex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment Related Adverse Events
Time Frame: up to 6 months (post-intervention)
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.
Time Frame: Baseline up to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Time Frame: Baseline, 6 months.
Treatment efficacy will be assessed via the change of participants achieving any decrease in Peyronie's disease Questionnaire (PDQ) sub-domain scoring from baseline. The sub-domains that will be assessed in primary outcome is Psychological and Physical Symptoms and Symptom Bother. PDQ is a validated 15-item questionnaire that assess Psychological and Physical Symptoms, Symptom Bother, and Penile Pain subdomains. The Psychological and Physical Symptoms subdomain is measured from 0 to 24 (most severe symptoms). Symptom Bother subdomain is measured from 0 to 30 (most severe pain).
Baseline, 6 months.
Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores
Time Frame: Baseline, 6 months
IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Endo USA Inc., a Keenova Therapeutics Company

Investigators

  • Principal Investigator: Thomas Masterson, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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