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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01244256
Other study ID # BCGGLE10407
Secondary ID
Status Suspended
Phase Phase 2/Phase 3
First received
Last updated
Start date April 2007
Est. completion date September 2007

Study information

Verified date November 2022
Source Azidus Brasil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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..


Recruitment information / eligibility

Status Suspended
Enrollment 80
Est. completion date September 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Clotrimazole + Gentamicin + Beclomethasone
Treatment with Clotrimazole + Gentamicin + Beclomethasone
Clotrimazole + Gentamicin
Treatment with Clotrimazole + Gentamicin

Locations

Country Name City State
Brazil LAL Clinica Valinhos SP

Sponsors (1)

Lead Sponsor Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of the treatment in patient with infected dermatoses 21 days of treatment
Secondary evaluate the safety and tolerability of both formulations in the course of treatmen 21 days of treatment
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