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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{1 3 4 5 9}

Research Team

Thomas A Masterson, MD

Principal Investigator

University of Miami

Eligibility 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°.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Netherlands 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. [2022]

3. England 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. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Efficacy and safety of collagenase Clostridium histolyticum in Peyronie's disease following a modified treatment protocol. [2021]

5. England 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). [2023]

6. England 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. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

Collagenase Clostridium histolyticum for the Treatment of Peyronie's Disease: The Development of This Novel Pharmacologic Approach. [2018]