Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-01 @ 3:25 PM
Study NCT ID:
NCT01244256
Status:
SUSPENDED
Last Update Posted:
2022-11-03
First Post:
2010-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated
Sponsor:
Azidus Brasil
Organization:
Study Overview
Official Title:
Isolation and Comparative Efficacy of the Combination of beclometasona0, 025% + Gentamicin 0.1% + Clotrimazole 1% Topical Dermatological Cream of GLENMARK PHARMACEUTICALS, in Patients Infected With Acne
Status:
SUSPENDED
Status Verified Date:
2022-11
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:
acne
Brief Summary:
The objective of this trial is to evaluate the comparative efficacy of the combination of Clotrimazole + Gentamicin + Beclomethasone in study subjects with a condition of contaminated dermatosis showing bilateral symmetrical lesions.
Detailed Description:
The specific objective is to evaluate, by means of analytical propedeutics medical improvement in clinical signs and symptoms related to acne infected, the use of the association: Clotrimazole, Gentamicin and Beclomethasone versus association: Clotrimazole and Gentamicin, which will first be randomized.
The study should be conducted with 20 research subjects aged over 18 years, of both sexes, showing the framework of bilateral lesions infected with acne, at any stage of evolution. The study subjects will receive treatment with both products, so they can use one in each lesion chosen at random, double-blind.
Thus, the proven efficacy and safety and taking all possible adverse events reported, the study sponsor hopes to obtain registration with the Ministry of Health of this new association in the country.
The association made a proposal was developed by the Laboratory Glenmark Pharmaceuticals Ltd..
The study should be conducted with 20 research subjects aged over 18 years, of both sexes, showing the framework of bilateral lesions infected with acne, at any stage of evolution. The study subjects will receive treatment with both products, so they can use one in each lesion chosen at random, double-blind.
Thus, the proven efficacy and safety and taking all possible adverse events reported, the study sponsor hopes to obtain registration with the Ministry of Health of this new association in the country.
The association made a proposal was developed by the Laboratory Glenmark Pharmaceuticals Ltd..
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: