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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Peyronie Disease

Intervention / Treatment
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* Device: Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, open-label, single-arm, multicentric, pilot clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HiLow hyaluronic acid sodium salt for intralesional penile injection<br>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<br>* 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]<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 |