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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:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01244256
First received: October 22, 2010
Last updated: November 18, 2010
Last verified: April 2007
History of Changes
  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 Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Efficacy of the treatment in patient with infected dermatoses [ Time Frame: 21 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluate the safety and tolerability of both formulations in the course of treatmen [ Time Frame: 21 days of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244256

Locations
Brazil
LAL Clinica
Valinhos, SP, Brazil, 13276245
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Investigators
Principal Investigator: Alexandre Frederico, médico L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

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
Study First Received: October 22, 2010
Last Updated: November 18, 2010
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Folliculitis
Hair Diseases
Skin Diseases
Beclomethasone
Clotrimazole
Miconazole
Gentamicins
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Infective Agents, Local
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013