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

Pilot Study to Evaluate the Safety and Efficacy of 3.2% High (HHA) and Low (LHA) Molecular Weight Hyaluronic Acid Sodium Salt [32 Mg (HHA) + 32 Mg (LHA) / 2 Ml] for Intralesional Penile Injection in Peyronie's Disease

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.

Study Overview

• Status: Completed
• Conditions: Peyronie Disease
• Intervention / Treatment: Device: Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy
    • U.O.C. Urologia, Azienda Ospedaliero Universitaria Mater Domini di Catanzaro
  • Macerata, Italy
    • Azienda Ospedaliero Universitaria delle Marche
  • Milano, Italy, 20122
    • Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: 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]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penile curvature	Evaluation of the amelioration in the degree of curvature of the penis measured using a goniometer	Day 0, Day 75, Day 180
Penile length	Evaluation of the amelioration in the length of the penis after the induction of penile erection	Day 0, Day 75, Day 180
Patient's global impression of improvement	Evaluation of patient's global impression of improvement by Patient Global Impression of Improvement (PGI-I) scale with a score from 1 (very much better) to 7 (very much worse).	Day 75, Day 180

Collaborators and Investigators

• Sponsor: IBSA Farmaceutici Italia Srl
• Investigators: Principal Investigator: Franco Gadda, MD, Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2023
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Connective Tissue Diseases; Penile Diseases; Penile Induration; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: IPPPRVL/01-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No