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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244256
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Azidus Brasil
  Purpose
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.

Condition Intervention Phase
Folliculitis Drug: Clotrimazole + Gentamicin + Beclomethasone Drug: Clotrimazole + Gentamicin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Efficacy of the treatment in patient with infected dermatoses [ Time Frame: 21 days of treatment ]

Secondary Outcome Measures:
  • evaluate the safety and tolerability of both formulations in the course of treatmen [ Time Frame: 21 days of treatment ]

Estimated Enrollment: 80
Study Start Date: April 2007
Estimated Study Completion Date: September 2007
Estimated Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with Clotrimazole + Gentamicin + Beclomethasone Drug: Clotrimazole + Gentamicin + Beclomethasone
Treatment with Clotrimazole + Gentamicin + Beclomethasone
Active Comparator: Treatment with Clotrimazole + Gentamicin Drug: Clotrimazole + Gentamicin
Treatment with Clotrimazole + Gentamicin

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244256


Locations
Brazil
LAL Clinica
Valinhos, SP, Brazil, 13276245
Sponsors and Collaborators
Azidus Brasil
Investigators
Principal Investigator: Alexandre Frederico, médico Azidus Brasil
  More Information

Responsible Party: Dr. Alexandre Frederico, L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01244256     History of Changes
Other Study ID Numbers: BCGGLE10407
First Submitted: October 22, 2010
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
Last Verified: April 2007

Additional relevant MeSH terms:
Folliculitis
Hair Diseases
Skin Diseases
Gentamicins
Beclomethasone
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents