Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated (acne)
Primary Purpose
Folliculitis
Status
Suspended
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Clotrimazole + Gentamicin + Beclomethasone
Clotrimazole + Gentamicin
Sponsored by
About this trial
This is an interventional treatment trial for Folliculitis
Eligibility 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
Sites / Locations
- LAL Clinica
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment with Clotrimazole + Gentamicin + Beclomethasone
Treatment with Clotrimazole + Gentamicin
Arm Description
Outcomes
Primary Outcome Measures
Efficacy of the treatment in patient with infected dermatoses
Secondary Outcome Measures
evaluate the safety and tolerability of both formulations in the course of treatmen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01244256
Brief Title
Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated
Acronym
acne
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 Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Study Start Date
April 2007 (Actual)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2007 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azidus Brasil
4. Oversight
Data Monitoring Committee
No
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Folliculitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Clotrimazole + Gentamicin + Beclomethasone
Arm Type
Experimental
Arm Title
Treatment with Clotrimazole + Gentamicin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Clotrimazole + Gentamicin + Beclomethasone
Intervention Description
Treatment with Clotrimazole + Gentamicin + Beclomethasone
Intervention Type
Drug
Intervention Name(s)
Clotrimazole + Gentamicin
Intervention Description
Treatment with Clotrimazole + Gentamicin
Primary Outcome Measure Information:
Title
Efficacy of the treatment in patient with infected dermatoses
Time Frame
21 days of treatment
Secondary Outcome Measure Information:
Title
evaluate the safety and tolerability of both formulations in the course of treatmen
Time Frame
21 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Frederico, médico
Organizational Affiliation
Azidus Brasil
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAL Clinica
City
Valinhos
State/Province
SP
ZIP/Postal Code
13276245
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated
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