NCT01244256

Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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..

Conditions

• Folliculitis

Interventions

Type	Name	Description
DRUG	Clotrimazole + Gentamicin + Beclomethasone	Treatment with Clotrimazole + Gentamicin + Beclomethasone
DRUG	Clotrimazole + Gentamicin	Treatment with Clotrimazole + Gentamicin

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-08-01
• Completion: 2007-09-01
• First posted: 2010-11-19
• Last updated: 2022-11-03

Locations

1 site across 1 country: Brazil