Back to resultsSafety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronie's Disease (PD)
Primary Purpose
Peyronie Disease
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt
Sponsored by
About this trial
This is an interventional treatment trial for Peyronie Disease
Eligibility Criteria
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
Sites / Locations
- U.O.C. Urologia, Azienda Ospedaliero Universitaria Mater Domini di Catanzaro
- Azienda Ospedaliero Universitaria delle MarcheRecruiting
- Fondazione IRCSS Cà Granda Ospedale Maggiore PoliclinicoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HiLow hyaluronic acid sodium salt for intralesional penile injection
Arm Description
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
Outcomes
Primary Outcome Measures
Incidence of adverse events
Evaluation of the safety of the treatment by measurement of the incidence of adverse events
Secondary Outcome Measures
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).
Penile curvature
Evaluation of the amelioration in the degree of curvature of the penis measured using a goniometer
Penile length
Evaluation of the amelioration in the length of the penis after the induction of penile erection
Full Information
NCT ID
NCT05871177
First Posted
May 12, 2023
Last Updated
May 23, 2023
Sponsor
IBSA Farmaceutici Italia Srl
1. Study Identification
Unique Protocol Identification Number
NCT05871177
Brief Title
Safety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronie's Disease (PD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IBSA Farmaceutici Italia Srl
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, open-label, single-arm, multicentric, pilot clinical study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HiLow hyaluronic acid sodium salt for intralesional penile injection
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt
Intervention Description
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]
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Evaluation of the safety of the treatment by measurement of the incidence of adverse events
Time Frame
From Day 0 to Day 180
Secondary Outcome Measure Information:
Title
Patient's global impression of improvement
Description
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).
Time Frame
Day 75, Day 180
Title
Penile curvature
Description
Evaluation of the amelioration in the degree of curvature of the penis measured using a goniometer
Time Frame
Day 0, Day 75, Day 180
Title
Penile length
Description
Evaluation of the amelioration in the length of the penis after the induction of penile erection
Time Frame
Day 0, Day 75, Day 180
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuliana Roselli, PhD
Phone
+390371617373
Email
giuliana.roselli@ibsa.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Gadda, MD
Organizational Affiliation
Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O.C. Urologia, Azienda Ospedaliero Universitaria Mater Domini di Catanzaro
City
Catanzaro
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocco Damiano, Prof.
Phone
+3909613647219
Email
damiano@unicz.it
Facility Name
Azienda Ospedaliero Universitaria delle Marche
City
Macerata
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Fabiani, MD
Phone
+393474865381
Email
andreadoc1@libero.it
Facility Name
Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Gadda, MD
Phone
+390255034501
Email
franco.gadda@policlinico.mi.it
First Name & Middle Initial & Last Name & Degree
Franco Gadda, MD
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronie's Disease (PD)
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