CCH for Peyronie's Disease

Recruiting at 1 trial location

Overseen By Manuel Molina, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: University of Miami

Disqualifiers: Previous penile surgery, Priapism, Severe erectile dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and side effects of injecting collagenase clostridium histolyticum (CCH) into the scar tissue (plaque) of the penis in men with Peyronie's Disease (PD). It targets those who have already received platelet-rich plasma (PRP) injections but still experience a curved penis. Participants should have noticeable plaque and a curve between 30° and 90°. The study aims to determine if CCH can effectively treat PD following PRP. As a Phase 4 trial, this research involves an FDA-approved treatment, seeking to understand its benefits for more patients.

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 is the safety track record for Collagenase Clostridium Histolyticum (CCH)?

Research has shown that collagenase clostridium histolyticum (CCH) is often used to treat Peyronie's disease. In earlier studies, common side effects included swelling, bruising, and pain at the injection site. These side effects occurred in more than 25% of patients, exceeding those in the placebo group. However, these side effects are usually manageable.

The FDA has already approved CCH for treating Peyronie's disease, indicating it is generally safe for this condition. Since this trial is in a later stage, it suggests that earlier trials have demonstrated the treatment's safety.

Overall, many patients have tolerated CCH well, but individual experiences can differ. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Collagenase Clostridium Histolyticum (CCH) for Peyronie's Disease because it offers a unique approach compared to traditional surgical or mechanical treatments. Most treatments for Peyronie's focus on physically altering the penile structure or removing scar tissue, but CCH works differently by breaking down the collagen in the plaques causing the curvature. This enzymatic action can potentially correct the penile curvature non-surgically, making it less invasive and possibly offering quicker recovery times. This innovative mechanism of action has generated interest as it could provide an effective alternative with fewer risks and complications.

What is the effectiveness track record for Collagenase Clostridium Histolyticum (CCH) in treating Peyronie's Disease?

Research has shown that Collagenase Clostridium Histolyticum (CCH), which participants in this trial will receive, effectively treats Peyronie's Disease (PD). Studies have found that CCH can reduce the bend in the penis by 34%, with an average improvement of 17 degrees. The FDA has approved this treatment, and large studies with many participants have tested it. Those who closely follow the treatment plan often see even better results. Overall, CCH is considered a reliable option for reducing the bend in PD. ^{6 7 8 9 10}

Who Is on the Research Team?

Thomas A Masterson, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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°.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Collagenase Clostridium Histolyticum (CCH)

Trial Overview 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.

How Is the Trial Designed?

Group I: Collagenase Clostridium Histolyticum (CCH) Group Experimental Treatment 1 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 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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Endo Pharmaceuticals

Industry Sponsor

Trials

136

Recruited

33,700+

Matthew Davis

Endo Pharmaceuticals

Chief Medical Officer since 2016

MD

Scott Hirsch

Endo Pharmaceuticals

Chief Executive Officer

BA in Economics from Princeton University

Published Research Related to This Trial

Collagenase Clostridium histolyticum (CCH) has been established as the first FDA-approved nonsurgical treatment for Peyronie's disease (PD), addressing a significant need for effective therapies in this condition.

The development of CCH was driven by research into the collagen structure of PD plaques, leading to clinical studies that not only validated its efficacy but also resulted in the creation of the Peyronie's Disease Questionnaire to assess psychosexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagenase Clostridium histolyticum for the Treatment of Peyronie's Disease: The Development of This Novel Pharmacologic Approach. Gelbard, MK., Chagan, L., Tursi, JP.[2018]

In a study involving 31 patients with Peyronie's disease, a modified treatment protocol using collagenase Clostridium histolyticum (CCH) resulted in an 80.6% improvement in curvature, with an average reduction of 20.65 degrees, demonstrating its efficacy.

The modified protocol was found to be safe, as no treatment-related adverse events were reported, suggesting it could be a viable alternative to the standard, more resource-intensive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of collagenase Clostridium histolyticum in Peyronie's disease following a modified treatment protocol. García Cruz, E., Mercader Barrull, C., Camacho Rovira, D., et al.[2021]

Collagenase Clostridium histolyticum (CCH) usage for Peyronie's disease has significantly increased since its FDA approval in 2013, while the use of surgical options has steadily declined, indicating a shift in treatment preferences among patients.

Despite CCH being more expensive overall compared to surgical treatments, the out-of-pocket costs for patients are similar, making it a viable option for those seeking non-surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost of Intralesional Collagenase Clostridium Histiolyticum Therapy Versus Surgery for the Management of Peyronie's Disease: A Claims-Based Analysis (2009-2019). Walton, EL., Quinn, TP., Mulloy, E., et al.[2023]

In a study of 13 patients with Peyronie's disease, an intensive treatment protocol using collagenase clostridium histolyticum (CCH) resulted in a significant improvement in penile curvature for 76.9% of participants, with an average reduction of 19 degrees in curvature after treatment.

The treatment was found to be safe, with only mild adverse effects reported, and the new protocol allows for better patient adherence due to its shorter overall duration compared to previous methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy Study of Collagenase Clostridium Histolyticum Applied With an Intensive Protocol in the Treatment of Peyronie's Disease. Melgarejo-Segura, MT., Funes-Padilla, C., Morales-Martínez, A., et al.[2021]

Collagenase Clostridium Histolyticum (CCH) significantly improved penile curvature and reduced discomfort in men with Peyronie's disease, based on results from the 52-week phase III IMPRESS I and II studies.

CCH was generally well tolerated, with serious side effects occurring in less than 1% of patients, indicating it is a safe and effective minimally invasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagenase Clostridium Histolyticum: A Review in Peyronie's Disease. Dhillon, S.[2018]

Collagenase Clostridium histolyticum (CCH), known as Xiaflex, is an effective non-surgical treatment for Peyronie's disease, but it can lead to rare complications such as lateral herniation of the tunica albuginea, as demonstrated in a case involving a 58-year-old male.

The patient experienced a painless swelling on the left side of the penis after CCH injections, indicating a potential herniation rather than a rupture, highlighting the need for awareness of this rare side effect during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateral herniation during treatment with collagenase Clostridium histolyticum (Xiaflex) for Peyronie's disease. Gannon, MK., Pearlman, AM.[2021]

In a study of 49 patients with Peyronie's disease, collagenase Clostridium histolyticum (CCh) treatment significantly reduced penile curvature by an average of 15.4 degrees (32.4%), improving the ability to perform intercourse by 29.1%.

While CCh showed promising results in reducing curvature and improving subjective symptoms, there were some safety concerns, including a 10.2% incidence of notable bleeding events, with one case resulting in a penile fracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peyronie's Disease and Injectable Collagenase Clostridium histolyticum: Safety, Efficacy, and Improvements in Subjective Symptoms. Yang, KK., Bennett, N.[2022]

In a phase 3 study involving 347 men with Peyronie's disease, collagenase clostridium histolyticum (CCH) demonstrated a significant mean improvement of 34.4% in penile curvature deformity and a reduction of 3.3 points in the PD symptom bother score after 36 weeks of treatment.

CCH was generally well tolerated, with most adverse events being mild or moderate, and only three serious treatment-related adverse events were reported, all of which resolved with treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. Levine, LA., Cuzin, B., Mark, S., et al.[2022]

In a study of 53 patients with Peyronie's disease, a new modified treatment protocol using only three injections of collagenase clostridium histolyticum (CCH) resulted in a significant improvement in penile curvature, with 96.2% of patients showing an average reduction of 17.36° from a baseline curvature of 54° (P < 0.001).

The modified protocol was found to be safe and well-tolerated, with only mild and transient local side effects, and its efficacy was comparable to traditional protocols that required eight injections, making it a more cost-effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie's disease using a new modified shortened protocol. Abdel Raheem, A., Capece, M., Kalejaiye, O., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8451611/

Peyronie's disease – outcomes of collagenase clostridium ... The capstone CCh study was the IMPRESS trial thatshowed a 34% reduction in curvature with a mean (SD) – 17.0 (14.8)° reduction with IL CCh,while men in the ...

2. peyronies-disease.xiaflex.com peyronies-disease.xiaflex.com/hcp/efficacy-safety/study-design/

Study Design XIAFLEX is the only FDA-approved treatment evaluated in 2 large multicenter studies of patients with Peyronie's disease (PD).

3. academic.oup.com academic.oup.com/jsm/article/22/5/794/8113152

Are patients undergoing intralesional collagenase Clostridium ... Overall compliance rate for CCH injection therapy was 70.89%. Greater curvature reduction was demonstrated in compliant patients. Common reasons ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429522008305

Improved Peyronie's Disease Curvature Outcomes Using a ... Results from the current study demonstrate significantly greater curvature and subjective improvements among men treated with a novel, more aggressive CCH ...

5. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003634

Comparison of Collagenase Clostridium histolyticum to ... Secondary outcomes demonstrated statistically greater improvements in curve improvement among Surgery men (65° vs 32.5°, P = .02) and better ...

6. peyronies-disease.xiaflex.com peyronies-disease.xiaflex.com/hcp/efficacy-safety/safety/

Safety | XIAFLEX® (collagenase clostridium histolyticum ... In the XIAFLEX clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/125338s109lbl.pdf

Xiaflex - accessdata.fda.gov XIAFLEX is supplied in single-use glass vials containing 0.9 mg of collagenase clostridium histolyticum as a sterile, lyophilized powder for reconstitution.

8. mayoclinic.org mayoclinic.org/drugs-supplements/collagenase-clostridium-histolyticum-injection-route/description/drg-20073911

Collagenase clostridium histolyticum (injection route) Collagenase clostridium histolyticum injection is used to treat Dupuytren's contracture with a palpable cord. It is also used to treat Peyronie's disease.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25388099/

Clinical safety and effectiveness of collagenase clostridium ... Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study · Authors.

10. molinahealthcare.com molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/common/pa-criteria/Xiaflex-collagenase-clostridium-histolyticum-C24319-A.pdf

Xiaflex (collagenase clostridium histolyticum) C24319-A Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute Phase Peyronie's Disease: A Multi-institutional Analysis.