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

NCT05871177 | Completed

• 1 other identifier: IPPPRVL/01-20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Peyronie Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Evaluation of the safety of the treatment by measurement of the incidence of adverse events

  From Day 0 to Day 180

Secondary Outcomes (3)

• Patient's global impression of improvement

  Day 75, Day 180

• Penile curvature

  Day 0, Day 75, Day 180

• Penile length

  Day 0, Day 75, Day 180

Study Arms (1)

HiLow hyaluronic acid sodium salt for intralesional penile injection

EXPERIMENTAL

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

Device: Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt

Interventions

Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt DEVICE

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

HiLow hyaluronic acid sodium salt for intralesional penile injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead

Study Sites (3)

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

Catanzaro, Italy

Location

Azienda Ospedaliero Universitaria delle Marche

Macerata, Italy

Location

Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

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

Study Officials

• Franco Gadda, MD

  Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, single-arm, multicentric, pilot clinical study

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: May 21, 2023
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

IT (3)