Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated
acne
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedNovember 3, 2022
November 1, 2022
4 months
October 22, 2010
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of the treatment in patient with infected dermatoses
21 days of treatment
Secondary Outcomes (1)
evaluate the safety and tolerability of both formulations in the course of treatmen
21 days of treatment
Study Arms (2)
Treatment with Clotrimazole + Gentamicin + Beclomethasone
EXPERIMENTALTreatment with Clotrimazole + Gentamicin
ACTIVE COMPARATORInterventions
Treatment with Clotrimazole + Gentamicin + Beclomethasone
Treatment with Clotrimazole + Gentamicin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azidus Brasillead
Study Sites (1)
LAL Clinica
Valinhos, São Paulo, 13276245, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Frederico, médico
Azidus Brasil
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator Dr. Alexandre Frederico
Study Record Dates
First Submitted
October 22, 2010
First Posted
November 19, 2010
Study Start
April 1, 2007
Primary Completion
August 1, 2007
Study Completion
September 1, 2007
Last Updated
November 3, 2022
Record last verified: 2022-11