Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871177
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-05-12
Brief Title:
Safety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronies Disease PD
Sponsor:
IBSA Farmaceutici Italia Srl
Organization:
IBSA Farmaceutici Italia Srl
Study Overview
Official Title:
Pilot Study to Evaluate the Safety and Efficacy of 32 High HHA and Low LHA Molecular Weight Hyaluronic Acid Sodium Salt 32 mg HHA 32 mg LHA 2 ml for Intralesional Penile Injection in Peyronies Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 months of active treatment and during follow-up
The scondary endpoint is the overall improvement of the clinical condition by evaluation of the patients 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
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 25 months of active treatment and during follow-up
The scondary endpoint is the overall improvement of the clinical condition by evaluation of the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None