NCT05871177

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: IBSA Farmaceutici Italia Srl · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Peyronie Disease

Interventions

Type	Name	Description
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 \[32 mg (HHA) + 32 mg (LHA) / 2 ml\]

Timeline

• Start date: 2023-05-21
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 2023-05-23
• Last updated: 2025-01-08

Locations

3 sites across 1 country: Italy