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Collagenase

Novel CCH Protocol for Peyronie's Disease

Phase 4
Recruiting
Led By Landon Trost, MD
Research Sponsored by Charitable Union for the Research and Education of Peyronie's Disease
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously completed 6-8 CCH injections
Men with Peyronie's Disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial compares the effects of a new CCH administration protocol in men who haven't responded to CCH before.

Who is the study for?
Men over 18 with Peyronie's Disease who've had little improvement from previous CCH treatments can join. They must have a significant curve in their penis (≥30 degrees), no past penile surgery except circumcision, and be able to get an erection suitable for sex. Severe plaque calcification or inability to complete the treatment disqualifies them.Check my eligibility
What is being tested?
The trial is testing a new way of giving CCH injections compared to the old method among men whose Peyronie's Disease didn't respond well before. It includes using a device called RestoreX after not responding to at least 6-8 prior CCH injections without this device.See study design
What are the potential side effects?
CCH may cause swelling, pain at the injection site, bruising, bleeding, and possibly penile fracture. The RestoreX device might lead to discomfort or skin issues where it contacts the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have completed 6-8 injections for my condition.
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I am a man with Peyronie's Disease.
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I am older than 18 years.
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I received CCH injections without a Restorex device, following the IMPRESS protocol.
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My condition slightly improved with previous CCH treatment.
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I have a noticeable hard lump in my penis, indicating Peyronie's Disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Penile Curvature
Peyronie's Disease Questionnaire Outcomes
Secondary outcome measures
Adverse events - 12 months - pain, sensation, swelling
Adverse events - 6 months - pain, sensation, swelling
Change in penile curvature durability
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Collagenase Clostridium HistolyticumExperimental Treatment2 Interventions
Men in this cohort would undergo baseline assessments followed by up to 8 injections of CCH (or until curvature is <15 degrees). Men would then undergo assessments 6 weeks later, followed by a 6-month no treatment phase and then final assessments.
Group II: Control - Crossover to CCHActive Control2 Interventions
Men in this cohort would undergo baseline assessments followed by no treatment for 6 months and then repeat assessments. Men would then cross-over to CCH treatment and undergo up to 8 injections (or until curvature is <15 degrees). Final assessments would then be performed 6 weeks following the final injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RestoreX
2018
N/A
~90

Find a Location

Who is running the clinical trial?

Charitable Union for the Research and Education of Peyronie's DiseaseLead Sponsor
3 Previous Clinical Trials
340 Total Patients Enrolled
1 Trials studying Peyronie's Disease
40 Patients Enrolled for Peyronie's Disease
Landon Trost, MDPrincipal InvestigatorCURE PD
1 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

CCH administration (Collagenase) Clinical Trial Eligibility Overview. Trial Name: NCT05108558 — Phase 4
Peyronie's Disease Research Study Groups: Collagenase Clostridium Histolyticum, Control - Crossover to CCH
Peyronie's Disease Clinical Trial 2023: CCH administration Highlights & Side Effects. Trial Name: NCT05108558 — Phase 4
CCH administration (Collagenase) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108558 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is CCH administration hazardous for individuals?

"Our team has confidently assigned CCH a safety rating of 3, as this stage 4 trial indicates the drug is approved for medical use."

Answered by AI

What are the hopes to be achieved by this trial?

"This trial, lasting 6 months, aims to assess Penile Curvature. Secondary objectives include evaluating the International Index of Erectile Function Outcomes between control and treatment groups at 6 months, comparing Peyronie's Disease Questionnaire results from baseline and 12 months in control men (using 15 items; subdomains - psychological & physical (Q1-6, 0-24), penile pain (Q7-9; 0-30), symptom bother (Q10-15; 0-16); 12 & 14 Y/N q's)), as well as assessing any changes in penile length between the two groups over"

Answered by AI

Are there any opportunities to join this research endeavor?

"Per the information on clinicaltrials.gov, this medical study is actively seeking applicants. The trial was initiated on September 20th 2021 and has undergone recent edits as of November 1st 2021."

Answered by AI

Are there any precedents of CCH being used as part of a medical experiment?

"As of now, 6 clinical trials for CCH administration are still ongoing with one trial in Phase 3. Of the 11 study sites offering it, most are located in Orem, Utah."

Answered by AI

For what purposes is CCH typically prescribed?

"CCH is commonly administered to treat palpable cord, as well as skin ulcers, peyronie's disease and penile deformities of up to 30 degrees."

Answered by AI

How many participants are currently recruited into this clinical investigation?

"Affirmative. Clinicaltrials.gov shows that this trial is searching for volunteers, having been first posted on September 20th 2021 and last modified on November 1st 2021. 40 people are needed at the solitary site offering enrolment into the study."

Answered by AI

Who else is applying?

What state do they live in?
South Dakota
Arizona
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
The Male Fertility and Peyronie's Clinic
Recent research and studies
clinicaltrials.govStudy
Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders
2021. "Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05108558.
All > Peyronies Disease
~16 spots leftby Dec 2025
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