NCT06649539

Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Charitable Union for the Research and Education of Peyronie's Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH. The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data. Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2. The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.

Detailed description

The current study would prospectively follow 40 men through the following treatment protocol: * Men would receive 4 series of CCH injections according to the protocol below, which represents a modified version of our most recently published technique.13 * Medication administered on back-to-back days * Total of 0.9 mg administered with each series, diluted to 0.8 mL * Mild in-office modeling performed on treatment day 2 of each series * Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising * Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series. * Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final series. * Note that men may stop sooner if they are satisfied before completing the 4 series. * If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol. * This would be performed 9-12 months after the 4th series of injections. * The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial. * The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total. At the time of initial enrollment, partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partner's overall support for the ongoing treatment protocol. Assessments and study questionnaires will be administered at baseline, with the 1st injection of each series, 6 weeks after completing the 4th series of CCH injections, and 1 year after completion of the final series of CCH injections.

Conditions

• Peyronie Disease

Interventions

Type	Name	Description
DRUG	Collagenase Clostridium Histolyticum	4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series. Total of 0.9 mg administered with each series, diluted to 0.8 mL
DEVICE	RestoreX	Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.
DRUG	Sildenafil	Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.

Timeline

• Start date: 2024-10-11
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2024-10-18
• Last updated: 2025-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study