Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2025-12-17 @ 4:35 PM
Study NCT ID:
NCT06392529
Status:
None
Last Update Posted:
2024-08-07 00:00:00
First Post:
2024-04-26 00:00:00
Brief Title:
Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis
Status:
None
Status Verified Date:
2024-08
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:
The current study will be prospective controlled randomized clinical trial. 28 female patients suffering from vulvovaginal candidiasis will be enrolled in the following 2 groups:
Gp 1 (Test group): including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups:
Gp 1a: will be treated with F2 VCZ loaded SP gel for 3 days. Gp 1 b: Will be treated with F2 VCZ loaded SP gel for 5 days. Gp 2 (Control group): including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a: will be treated with the Clotrimazole cream available in the market for 3 days.
Gp 2 b: Will be treated with the Clotrimazole cream available in the market for 5 days.
Smears will be taken from the patients before starting the therapeutic protocol and after finishing it. Compliance of the patients to the creams will be assesses
Gp 1 (Test group): including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups:
Gp 1a: will be treated with F2 VCZ loaded SP gel for 3 days. Gp 1 b: Will be treated with F2 VCZ loaded SP gel for 5 days. Gp 2 (Control group): including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a: will be treated with the Clotrimazole cream available in the market for 3 days.
Gp 2 b: Will be treated with the Clotrimazole cream available in the market for 5 days.
Smears will be taken from the patients before starting the therapeutic protocol and after finishing it. Compliance of the patients to the creams will be assesses
Detailed Description:
The current study will be prospective controlled randomized clinical trial 28 female patients suffering from vulvovaginal candidiasis will be enrolled in the following 2 groups
Gp 1 Test group including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups
Gp 1a will be treated with F2 VCZ loaded SP gel for 3 days Gp 1 b Will be treated with F2 VCZ loaded SP gel for 5 days Gp 2 Control group including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a will be treated with the Clotrimazole cream available in the market for 3 days
Gp 2 b Will be treated with the Clotrimazole cream available in the market for 5 days
Smears will be taken from the patients before starting the therapeutic protocol and after finishing it Compliance of the patients to the creams will be assesses
Gp 1 Test group including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups
Gp 1a will be treated with F2 VCZ loaded SP gel for 3 days Gp 1 b Will be treated with F2 VCZ loaded SP gel for 5 days Gp 2 Control group including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a will be treated with the Clotrimazole cream available in the market for 3 days
Gp 2 b Will be treated with the Clotrimazole cream available in the market for 5 days
Smears will be taken from the patients before starting the therapeutic protocol and after finishing it Compliance of the patients to the creams will be assesses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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