Clinical Trial Details
— Status: Suspended
Administrative data
NCT number |
NCT01244256 |
Other study ID # |
BCGGLE10407 |
Secondary ID |
|
Status |
Suspended |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
April 2007 |
Est. completion date |
September 2007 |
Study information
Verified date |
November 2022 |
Source |
Azidus Brasil |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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..