Clinical trial NCT05871177: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peyronie Disease
Lead sponsor: IBSA Farmaceutici Italia Srl
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open-label, single-arm, multicentric, pilot clinical study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: From Day 0 to Day 180
Secondary outcomes:
measure: Patient's global impression of improvement
timeFrame: Day 75, Day 180
measure: Penile curvature
timeFrame: Day 0, Day 75, Day 180
measure: Penile length
timeFrame: Day 0, Day 75, Day 180
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: U.O.C. Urologia, Azienda Ospedaliero Universitaria Mater Domini di Catanzaro
city: Macerata
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche
city: Milano
country: Italy
facility: Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCSS Cà Granda Ospedale Maggiore Policlinico
name: Franco Gadda, MD
role: PRINCIPAL_INVESTIGATOR
References: