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

Sponsor
IBSA Farmaceutici Italia Srl (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05871177
Collaborator
(none)
40
Enrollment
3
Locations
1
Arm
15.9
Anticipated Duration (Months)
13.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, open-label, single-arm, multicentric, pilot clinical studyProspective, open-label, single-arm, multicentric, pilot clinical study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 5, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HiLow hyaluronic acid sodium salt for intralesional penile injection

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
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]

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events [From Day 0 to Day 180]

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

Secondary Outcome Measures

  1. Patient's global impression of improvement [Day 75, Day 180]

    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).

  2. Penile curvature [Day 0, Day 75, Day 180]

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

  3. Penile length [Day 0, Day 75, Day 180]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 U.O.C. Urologia, Azienda Ospedaliero Universitaria Mater Domini di Catanzaro Catanzaro Italy
2 Azienda Ospedaliero Universitaria delle Marche Macerata Italy
3 Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico Milano Italy 20122

Sponsors and Collaborators

  • IBSA Farmaceutici Italia Srl

Investigators

  • Principal Investigator: Franco Gadda, MD, Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IBSA Farmaceutici Italia Srl
ClinicalTrials.gov Identifier:
NCT05871177
Other Study ID Numbers:
  • IPPPRVL/01-20
First Posted:
May 23, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Penile Induration
Hyaluronic Acid

Study Results

No Results Posted as of May 24, 2023