Peyronie DiseaseNCT05871177
Safety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronie's Disease (PD)
A study testing Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt in people with Peyronie Disease, run by IBSA Farmaceutici Italia Srl at 3 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Peyronie Disease
- What is being tested?
- Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesItaly
- Study dates
- 21 May 2023to 24 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
U.O.C. Urologia, Azienda Ospedaliero Universitaria Mater Domini di Catanzaro
Catanzaro
Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliero Universitaria delle Marche
Province of Macerata
About this study
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
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.
Read the 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
- Being tested
- Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-filled syringe of HiLow Hyaluronic Acid Sodium SaltDevice
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]
| Study group | Role | What they receive |
|---|---|---|
| HiLow hyaluronic acid sodium salt for intralesional penile injection | Experimental | 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 Receives: Device: Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Evaluation of the safety of the treatment by measurement of the incidence of adverse events
Measured: From Day 0 to Day 180
Secondary outcomes (3)
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).
Measured: Day 75, Day 180
Penile curvature
Evaluation of the amelioration in the degree of curvature of the penis measured using a goniometer
Measured: Day 0, Day 75, Day 180
Penile length
Evaluation of the amelioration in the length of the penis after the induction of penile erection
Measured: Day 0, Day 75, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start21 May 2023
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, single-arm, multicentric, pilot clinical study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Farmaceutici Italia Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franco Gadda, MD, Principal investigator, Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871177
- Sponsor's protocol ID
- IPPPRVL/01-20
- Status last verified
- Jan 2025
- First submitted
- 12 May 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05871177
- Acronym / sponsor ID
- IPPPRVL/01-20
- Conditions
- Peyronie Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IBSA Farmaceutici Italia SrlIndustry (pharma, biotech, devices)
- Study start
- 21 May 2023 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, single-arm, multicentric, pilot clinical study
| Arm | Type | Receives |
|---|---|---|
| HiLow hyaluronic acid sodium salt for intralesional penile injection | Experimental | Device: Pre-filled syringe of HiLow Hyaluronic Acid Sodium SaltFive 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- presence of hourglass deformity
- presence of calcified plaques
- congenital curvature of the penis
- previous penile surgery
- concomitant oral treatment for IPP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-filled syringe of HiLow Hyaluronic Acid Sodium SaltThe 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] | Device | HiLow hyaluronic acid sodium salt for intralesional penile injection |
Primary outcome
Incidence of adverse events
Time frame: From Day 0 to Day 180
Evaluation of the safety of the treatment by measurement of the incidence of adverse events
3 secondary outcomes
Patient's global impression of improvement
Time frame: Day 75, Day 180
Penile curvature
Time frame: Day 0, Day 75, Day 180
Penile length
Time frame: Day 0, Day 75, Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Gadda, MD principal investigator
Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-filled syringe of HiLow Hyaluronic Acid Sodium Salt in people with Peyronie Disease, run by IBSA Farmaceutici Italia Srl at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: From Day 0 to Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.