Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
NCT ID: NCT05777031
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
22 participants
INTERVENTIONAL
2023-10-02
2026-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
MALE
No
Sponsors
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University of Miami
OTHER
Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Thomas Masterson
Assistant professor
Principal Investigators
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Thomas Masterson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami - Desai Sethi Urology Institute
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20221234
Identifier Type: -
Identifier Source: org_study_id
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