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Trial record 4 of 15 for:    "Folliculitis"

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

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.
 
ClinicalTrials.gov Identifier: NCT01244256
Recruitment Status : Suspended
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
Azidus Brasil

Tracking Information
First Submitted Date  ICMJE October 22, 2010
First Posted Date  ICMJE November 19, 2010
Last Update Posted Date November 19, 2010
Study Start Date  ICMJE April 2007
Estimated Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2010)
Efficacy of the treatment in patient with infected dermatoses [ Time Frame: 21 days of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2010)
evaluate the safety and tolerability of both formulations in the course of treatmen [ Time Frame: 21 days of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Comparative Isolation of the Association Beclomethasone Clotrimzaol + + Gentamicin in Patients With Acne Contaminated
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Folliculitis
Intervention  ICMJE
  • Drug: Clotrimazole + Gentamicin + Beclomethasone
    Treatment with Clotrimazole + Gentamicin + Beclomethasone
  • Drug: Clotrimazole + Gentamicin
    Treatment with Clotrimazole + Gentamicin
Study Arms  ICMJE
  • Experimental: Treatment with Clotrimazole + Gentamicin + Beclomethasone
    Intervention: Drug: Clotrimazole + Gentamicin + Beclomethasone
  • Active Comparator: Treatment with Clotrimazole + Gentamicin
    Intervention: Drug: Clotrimazole + Gentamicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 18, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2007
Estimated Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01244256
Other Study ID Numbers  ICMJE BCGGLE10407
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Alexandre Frederico, L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Study Sponsor  ICMJE Azidus Brasil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandre Frederico, médico Azidus Brasil
PRS Account Azidus Brasil
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP