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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by University of Miami
Sponsor
University of Miami
Information Provided by (Responsible Party)
Thomas Masterson
Clinicaltrials.gov Identifier
NCT05777031
Other Study ID Numbers:
20221234
First Submitted
March 7, 2023
First Posted
March 19, 2023
Last Update Posted
March 22, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Peyronie DiseaseSexual Dysfunctions, PsychologicalGenital Diseases, Male
Drug: Collagenase Clostridium Histolyticum (CCH)

Study Design

Study TypeInterventional
Actual Enrollment22 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleSafety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease
Study Start DateOctober 1, 2023
Actual Primary Completion Date7mos 1w from now
Actual Study Completion Date7mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.

Outcome Measures

Primary Outcome Measures
  1. 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
  2. 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.
Secondary Outcome Measures
  1. Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
    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).
  2. Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsUniversity of Miami
Locations
University of Miami - Desai Sethi Urology Institute | Miami Florida, United States, 33136University of Miami | Miami Florida, United States, 33136
Investigators
Principal Investigator: Thomas Masterson, MD, University of Miami