Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089252
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2023-09-27
Brief Title:
Efficacy of Lazolex Gel in the Treatment of Herpes Simplex
Sponsor:
Iveriapharma LLC
Organization:
Iveriapharma LLC
Study Overview
Official Title:
Efficacy of Lazolex Gel in the Treatment of Herpes Simplex Mucocutaneous Infections and the Prevention of Recurrences A Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Study aimed to evaluate the efficacy and tolerance of Lazolex an emollient gel to treat mucocutaneous lesions caused by herpes simplex virus
Detailed Description:
A single-center single-arm open-label phase II clinical trial was conducted with 30 patients divided into two groups 15 patients with herpes simplex virus type 1 HSV-1 infections and 15 with herpes simplex virus type 2 HSV-2 infections All received topical treatment with Lazolex Gel four times daily for 10 days The efficacy and tolerance of the treatment were evaluated on day 10 and day 20 after the study started In addition recurrence rates were evaluated before treatment with Lazolex and after a 4-year follow-up period after treatment
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