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

IBSA

Status: Completed

Conditions: Peyronie Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05871177

IPPPRVL/01-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

HiLow hyaluronic acid sodium salt for intralesional penile injection

Experimental group

Description:

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

Treatment:

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