Peyronie Disease
Conditions
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.
Interventions
DEVICEPre-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
IBSA Farmaceutici Italia Srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open-label, single-arm, multicentric, pilot clinical study
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Penile curvature | Day 0, Day 75, Day 180 | Evaluation of the amelioration in the degree of curvature of the penis measured using a goniometer |
| Penile length | Day 0, Day 75, Day 180 | Evaluation of the amelioration in the length of the penis after the induction of penile erection |
Countries
Italy
Outcome results
None listed