Clinical Trial: Evaluation of Efficacy and Comparative Isolation of the Association Beclomethasone Clotrimzaol + + Gentamicin in Patients With Acne Contaminated
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
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 Ac
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 Summary:
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..
Sponsor: Azidus Brasil
Current Primary Outcome: Efficacy of the treatment in patient with infected dermatoses [ Time Frame: 21 days of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: evaluate the safety and tolerability of both formulations in the course of treatmen [ Time Frame: 21 days of treatment ]
Original Secondary Outcome: Same as current
Information By: Azidus Brasil
Dates:
Date Received: October 22, 2010
Date Started: April 2007
Date Completion: September 2007
Last Updated: November 18, 2010
Last Verified: April 2007
