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

IBSA Farmaceutici Italia Srl40 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peyronie Disease

Interventions

Pre-filled syringe of HiLow Hyaluronic Acid Sodium SaltDEVICE

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Incidence of adverse events

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

Time frame: From Day 0 to Day 180

Secondary Outcomes

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).

Time frame: Day 75, Day 180

Penile curvature

Evaluation of the amelioration in the degree of curvature of the penis measured using a goniometer

Time frame: Day 0, Day 75, Day 180

Penile length

Evaluation of the amelioration in the length of the penis after the induction of penile erection

Time frame: Day 0, Day 75, Day 180

Data from ClinicalTrials.gov

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