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

NCT05871177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-08

No results posted yet for this study

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.

Conditions

  • Peyronie Disease

Interventions

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

Sponsors & Collaborators

  • IBSA Farmaceutici Italia Srl

    lead INDUSTRY

Principal Investigators

  • Franco Gadda, MD · Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-21
Primary Completion
2024-05-24
Completion
2024-05-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05871177 on ClinicalTrials.gov