Evaluation of Efficacy and Comparative Isolation of the Association Beclomethasone Clotrimzaol + + Gentamicin in Patients With Acne Contaminated (acne)
|Folliculitis||Drug: Clotrimazole + Gentamicin + Beclomethasone Drug: Clotrimazole + Gentamicin||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|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|
- Efficacy of the treatment in patient with infected dermatoses [ Time Frame: 21 days of treatment ]
- evaluate the safety and tolerability of both formulations in the course of treatmen [ Time Frame: 21 days of treatment ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||September 2007|
|Estimated Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
|Experimental: Treatment with Clotrimazole + Gentamicin + Beclomethasone||
Drug: Clotrimazole + Gentamicin + Beclomethasone
Treatment with Clotrimazole + Gentamicin + Beclomethasone
|Active Comparator: Treatment with Clotrimazole + Gentamicin||
Drug: Clotrimazole + Gentamicin
Treatment with Clotrimazole + Gentamicin
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..
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244256
|Valinhos, SP, Brazil, 13276245|
|Principal Investigator:||Alexandre Frederico, médico||Azidus Brasil|