CCH for Peyronie's Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Miami
Disqualifiers: Previous penile surgery, Priapism, Severe erectile dysfunction, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
What data supports the effectiveness of the drug Collagenase Clostridium Histolyticum (CCH) for treating Peyronie's Disease?
Research shows that Collagenase Clostridium Histolyticum (CCH) is effective and safe for treating Peyronie's Disease, as it is the only approved non-surgical treatment that has demonstrated positive results in clinical trials.
12345Is Collagenase Clostridium Histolyticum (CCH) safe for humans?
CCH, also known as Xiaflex, is generally well tolerated in treating Peyronie's disease, with most side effects being mild or moderate. Serious side effects like penile hematoma (bruising) or corporal rupture (tear in the penis tissue) are rare but possible.
12678How is the drug Collagenase Clostridium Histolyticum unique for treating Peyronie's Disease?
Collagenase Clostridium Histolyticum (CCH) is unique because it is the only FDA-approved nonsurgical treatment for Peyronie's Disease, offering a minimally invasive option that can reduce the need for surgery. It works by breaking down collagen, which is a key component of the scar tissue causing the condition.
13459Eligibility Criteria
Men with Peyronie's Disease who have a significant bend in their penis (30° to <90°) and have had previous PRP treatments without surgery. They should be stable as judged by the doctor, able to consent, follow study procedures, and not planning any interfering medical procedures.Inclusion Criteria
Agree to comply with all study related tests/procedures
Be able to provide written informed consent
My penile curvature is between 30° and 90°.
+3 more
Exclusion Criteria
Previous history of priapism or penile fracture
Medically unfit for sexual intercourse as deemed by the principal investigator
I have an hour-glass shaped deformity.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive intralesional collagenase clostridium histolyticum (CCH) injections following prior PRP treatment. There are 8 total treatments, with 2 injections per cycle, 24-72 hours apart, followed by a 6-week break, for a maximum of 4 cycles.
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in erectile function and Peyronie's Disease symptoms.
6 months
Participant Groups
The trial is testing the safety and effects of injecting CCH into penile plaque in men who've previously received PRP injections for Peyronie's Disease. The goal is to see if this treatment can help correct penile curvature after initial PRP therapy.
1Treatment groups
Experimental Treatment
Group I: Collagenase Clostridium Histolyticum (CCH) GroupExperimental Treatment1 Intervention
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) is already approved in United States, European Union, United States for the following indications:
🇺🇸 Approved in United States as Xiaflex for:
- Dupuytren's contracture
- Peyronie's disease
- Cellulite
🇪🇺 Approved in European Union as Xiaflex for:
- Dupuytren's contracture
- Peyronie's disease
🇺🇸 Approved in United States as Qwo for:
- Cellulite
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Miami - Desai Sethi Urology InstituteMiami, FL
University of MiamiMiami, FL
Loading ...
Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
Endo PharmaceuticalsIndustry Sponsor
References
Peyronie's Disease and Injectable Collagenase Clostridium histolyticum: Safety, Efficacy, and Improvements in Subjective Symptoms. [2022]To report on an early adopter series of collagenase Clostridium histolyticum (CCh) for Peyronie's disease (PD). Postapproval studies of CCh have been anticipated after recent Food and Drug Administration authorization of its use for men with PD as definitive and durable nonsurgical interventions have been long desired.
Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. [2022]Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment for Peyronie's disease (PD).
Safety and Efficacy Study of Collagenase Clostridium Histolyticum Applied With an Intensive Protocol in the Treatment of Peyronie's Disease. [2021]Collagenase clostridium histolyticum (CCH) is a treatment for Peyronie's disease (PD) whose efficacy and safety has been demonstrated using a classic protocol and a shortened protocol.
Efficacy and safety of collagenase Clostridium histolyticum in Peyronie's disease following a modified treatment protocol. [2021]Collagenase Clostridium histolyticum (CCH) is the only approved treatment for conservative management of Peyronie's disease (PD) that has demonstrated efficacy and safety in clinical trials. However, as the standard treatment protocol is time and resource consuming, we are introducing a new CCH treatment protocol with a more cost-effective profile. Our goal is to evaluate its efficacy and safety.
Cost of Intralesional Collagenase Clostridium Histiolyticum Therapy Versus Surgery for the Management of Peyronie's Disease: A Claims-Based Analysis (2009-2019). [2023]Collagenase Clostridium histolyticum (CCH), which was approved by the FDA for the treatment of Peyronie's disease (PD) in 2013, may obviate the need for surgery but its historically high cost must be considered when offering CCH vs surgical intervention to affected patients.
Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie's disease using a new modified shortened protocol. [2018]Label="OBJECTIVES">To evaluate the efficacy and safety of collagenase clostridium histolyticum (CCH; Xiapex® , Xiaflex® ) in the treatment of Peyronie's disease (PD) using a new modified treatment protocol that aims at reducing the number of injections needed and reducing patient visits, thus reducing the duration and cost of treatment.
Collagenase Clostridium Histolyticum: A Review in Peyronie's Disease. [2018]Collagenase Clostridium Histolyticum (CCH) (Xiaflex(®), Xiapex(®)) intralesional injection is a mixture of class I (AUX-I) and class II (AUX-II) clostridial collagenases. It is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of ≥ 30° at the start of therapy. This article reviews the efficacy and tolerability of CCH in this indication and briefly summarizes its pharmacology. CCH treatment significantly improved penile curvature deformity and reduced patient-reported bother associated with Peyronie's disease in the 52-week, double-blind, phase III IMPRESS I and II studies. Treatment benefit with CCH was also seen in 36-week, open-label studies, providing further support for its efficacy. CCH was generally well tolerated in patients with Peyronie's disease, with most treatment-related adverse events being of mild or moderate severity. Serious treatment-related adverse events (penile haematoma or corporal ruptures) were reported in
Lateral herniation during treatment with collagenase Clostridium histolyticum (Xiaflex) for Peyronie's disease. [2021]Collagenase Clostridium histolyticum (CCH), also know as Xiaflex, with penile modeling is considered to be the gold standard non-surgical option for management of Peyronie's disease and is known to be safe and efficacious. Corporal rupture is a rare but known adverse event of CCH treatment, however there are limited studies describing corporal herniation without rupture. Here we present a patient who experienced a rare complication following CCH injections for Peyronie's disease: lateral herniation of the tunica albuginea in the setting of a dorsal penile plaque.
Collagenase Clostridium histolyticum for the Treatment of Peyronie's Disease: The Development of This Novel Pharmacologic Approach. [2018]The conception of collagenase Clostridium histolyticum (CCH) as treatment for Peyronie's disease (PD) was a vital first step in providing a nonsurgical, minimally invasive FDA-approved treatment for men with PD.