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

Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Folliculitis

Intervention: Clotrimazole + Gentamicin + Beclomethasone (Drug); Clotrimazole + Gentamicin (Drug)

Phase: Phase 2/Phase 3

Status: Suspended

Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Official(s) and/or principal investigator(s):
Alexandre Frederico, m├ędico, Principal Investigator, Affiliation: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Efficacy of the treatment in patient with infected dermatoses

Secondary outcome: evaluate the safety and tolerability of both formulations in the course of treatmen

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..

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

LAL Clinica, Valinhos, SP 13276245, Brazil
Additional Information

Starting date: April 2007
Last updated: November 18, 2010

Page last updated: August 23, 2015

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