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NCT Number: NCT05777031

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Peyronie Disease Connective Tissue Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Penile Diseases Penile Induration Sexual Dysfunctions, Psychological Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

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.

Other names: Xiaflex

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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