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, médico, 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
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