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

Phase 2

Suspended

• Conditions: Folliculitis
• Interventions: Drug: Clotrimazole + Gentamicin + Beclomethasone; Drug: Clotrimazole + Gentamicin

• Registration Number: NCT01244256
• Lead Sponsor: Azidus Brasil

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..

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-08
• Study Completion: 2007-09
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Subject search of both sexes, regardless of color or social class
• From age to 18, with good mental health
• Carriers of two outbreaks of acne contaminated
• Subjects who agree to return follow-up visits
• Research subjects who agree to participate and sign the Deed of Consent

Exclusion Criteria

• Subject Research carriers of susceptibility to gentamicin
• Research subjects suffering from sensitivity to clotrimazole
• Research subjects suffering from sensitivity to beclomethasone
• Research subjects who are making use of steroids or steroidal anti-inflammatory and non-steroidal drugs or who made use of topical or oral 15 days ago
• Research subjects who are doing immunosuppressive treatment
• Research subjects with a diagnosis of eosinophilic folliculitis or Pseudo-folliculitis barbae and groin
• Pregnant and lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment with Clotrimazole + Gentamicin + Beclomethasone	Clotrimazole + Gentamicin + Beclomethasone	-
Treatment with Clotrimazole + Gentamicin	Clotrimazole + Gentamicin	-

Primary Outcome Measures

Name	Time	Method
Efficacy of the treatment in patient with infected dermatoses	21 days of treatment

Secondary Outcome Measures

Name	Time	Method
evaluate the safety and tolerability of both formulations in the course of treatmen	21 days of treatment

Trial Locations

Locations (1)

LAL Clinica; 🇧🇷 Valinhos, SP, Brazil