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

Peyronie Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05871177
• Other study ID #: IPPPRVL/01-20
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2023
• Source: IBSA Farmaceutici Italia Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Penile Induration
• Peyronie Disease

Intervention

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]

Locations

Country	Name	City	State
Italy	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	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Farmaceutici Italia Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Penile curvature	Evaluation of the amelioration in the degree of curvature of the penis measured using a goniometer	Day 0, Day 75, Day 180
Secondary	Penile length	Evaluation of the amelioration in the length of the penis after the induction of penile erection	Day 0, Day 75, Day 180