Safety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronie's Disease (PD)

NCT ID: NCT05871177

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-21
• Study Completion Date: 2024-05-24

Brief Summary

Prospective, open-label, single-arm, multicentric, pilot clinical study to confirm the safety of HiLow hyaluronic acid sodium salt for intralesional penile injection in patients affected by PD.

Detailed Description

Prospective, open-label, single-arm, multicentric, pilot clinical study to confirm the safety of HiLow hyaluronic acid sodium salt for intralesional penile injection in patients affected by PD.

Fourty patients aged 18-75 and affected by PD in the acute phase will be enrolled in the study.

The primary endpoint is the incidence of adverse events with causal relationship during the 2.5 months of active treatment and during follow-up.

The scondary endpoint is the overall improvement of the clinical condition by evaluation of the patient's global improvement (PGI-I scale), the amelioration in the degree of the curvature of the penis and the amelioration in the length of the penis after the induction of penile erection.

Conditions

Peyronie Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HiLow hyaluronic acid sodium salt for intralesional penile injection

Five intralesional injections of HiLow hyaluronic acid sodium salt will be administered in total to men affected by PD every two weeks (for a total period of 2.5 months). Patients will be then followed-up for 3 months.

The following visits are scheduled:

Day 0: basal visit Day 15: injection n.1 Day 30: injection n.2 Day 45: injection n.3 Day 60: injection n.4 Day 75: injection n.5 Day 180: end of follow up

Group Type: EXPERIMENTAL

Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt

Intervention Type: DEVICE

The medical device consists of a pre-filled syringe containing 3.2% Hyaluronic Acid Sodium Salt with high and low molecular weight \[32 mg (HHA) + 32 mg (LHA) / 2 ml\]

Interventions

Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt

The medical device consists of a pre-filled syringe containing 3.2% Hyaluronic Acid Sodium Salt with high and low molecular weight \[32 mg (HHA) + 32 mg (LHA) / 2 ml\]

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• basal degree of penile curvature not less than 30°
• preserved erection
• documented absence of coagulation defects (at least one examination of coagulation factors within the 3 months prior to the start of the study)
• written informed consent

Exclusion Criteria

• presence of hourglass deformity
• presence of calcified plaques
• congenital curvature of the penis
• previous penile surgery
• concomitant oral treatment for IPP
• ongoing intralesional therapy or in the 3 months prior to the start of the study
• use of any traction device
• clinically stable disease
• history of symptomatic disease > 12 months
• known hypersensitivity or allergies to the components of the product
• any other clinical condition judged by the investigator not to be compatible with the participation in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

IBSA Farmaceutici Italia Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franco Gadda, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico

Locations

U.O.C. Urologia, Azienda Ospedaliero Universitaria Mater Domini di Catanzaro

Catanzaro, , Italy

Azienda Ospedaliero Universitaria delle Marche

Macerata, , Italy

Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Countries

Italy

Other Identifiers

IPPPRVL/01-20

Identifier Type: -

Identifier Source: org_study_id