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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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05871177
Study type Interventional
Source IBSA Farmaceutici Italia Srl
Contact
Status Active, not recruiting
Phase N/A
Start date May 5, 2023
Completion date March 31, 2024
View Details
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