Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders

NCT05108558 | Active Not Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: CUREPD 103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Compare key clinical outcomes between controls and men treated with a novel CCH administration protocol among men previously unresponsive to CCH administration.

Conditions

Peyronie's Disease

Outcome Measures

Primary Outcomes (2)

• Penile Curvature

  Compare the change in degree of penile curvature from baseline (using a goniometer) between control and treatment groups at 6 months

  6 months

• Peyronie's Disease Questionnaire Outcomes

  Compare Peyronie's Disease Questionnaire outcomes between control and treatment groups at 6 months using the Peyronie's Disease Questionnaire (15 items; subdomains - psychological and physical (Q1-6, 0-24), penile pain (Q7-9; 0-30), symptom bother (Q10-15; 0-16); 12 and 14 (Y/N q's); lower is better.

  6 months

Secondary Outcomes (9)

• International Index of Erectile Function Outcomes

  6 months

• Penile Curvature Compared to Baseline

  12 months

• Penile Length Compared to Baseline

  12 months

• Compare Peyronie's Disease Questionnaire to Baseline

  12 months

• Compare International Index of Erectile Function to baseline

  12 months

Study Arms (2)

Control - Crossover to CCH

ACTIVE COMPARATOR

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.

Drug: Control - Crossover to CCH; Device: RestoreX

Collagenase Clostridium Histolyticum

EXPERIMENTAL

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.

Drug: CCH administration; Device: RestoreX

Interventions

CCH administration DRUG

Patients will be randomized 3:1 into the CCH administration arm. After undergoing baseline assessments, this arm will receive up to 8 CCH injections, followed by final assessments 6 weeks later.

Also known as: Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum

Control - Crossover to CCH DRUG

Patients will be randomized 1:3 into the control arm. After undergoing baseline assessments, control men will not undergo treatments for 6 months. They will then have repeat assessments and receive up to 8 CCH injections. They will then have final assessments performed 6 weeks after treatment.

Also known as: Collagenase Clostridium Histolyticum

Control - Crossover to CCH

RestoreX DEVICE

Both treatment arms will incorporate the use of RestoreX for 30-60 minutes daily during CCH administration and continued until 6 weeks after final injection administration.

Collagenase Clostridium Histolyticum; Control - Crossover to CCH

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with Peyronie's Disease
• \>18 years old
• Curvature ≥30 degrees
• Previously completed 6-8 CCH injections
• Prior minimal (\<20% and/or \<10 degrees) responsiveness to CCH administration
• Prior CCH injections must have been performed without use of a Restorex traction device and used the IMPRESS protocol
• Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
• The patient exhibits a palpable plaque consistent with Peyronie's Disease

You may not qualify if:

• Prior surgical treatment on the penis (other than circumcision)
• Any contraindications to CCH - as determined by the PI
• Inability to complete 8 additional CCH injections
• Severe plaque calcification (i.e. \>1 cm shadowing)

Sponsors & Collaborators

• Charitable Union for the Research and Education of Peyronie's Disease: lead

Study Sites (1)

The Male Fertility and Peyronie's Clinic

Orem, Utah, 84057, United States

Location

MeSH Terms

Conditions

Penile Induration

Interventions

Microbial Collagenase

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Landon Trost, MD

  CURE PD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Photography will be obtained where possible, with outcomes assessed based on the photographs. The care provider obtaining measurements will also be blinded as to baseline outcomes and results with follow-up assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients meeting criteria who have consented will be randomized to either control or CCH x 6 months, followed by a cross-over phase where controls will receive CCH. See Figure 1 for full study schema. 1. Control. 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 the CCH treatment phase and undergo up to 8 injections (or until curvature is \<15 degrees, whichever comes first). Final assessments would then be performed 6 weeks following the final injection. 2. CCH followed by observation. Men in this cohort would undergo baseline assessments followed by up to 8 injections of CCH (or until curvature is \<15 degrees). Assessments would then be performed 6 weeks after completion of treatment. Men then would not undergo any additional treatments for 6 months, after which they would have final assessments performed.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 5, 2021
• Study Start: September 20, 2021
• Primary Completion: December 20, 2025
• Study Completion (Estimated): September 20, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)