Folliculitis
Conditions
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..
Interventions
DRUGClotrimazole + Gentamicin + Beclomethasone
Treatment with Clotrimazole + Gentamicin + Beclomethasone
DRUGClotrimazole + Gentamicin
Treatment with Clotrimazole + Gentamicin
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the treatment in patient with infected dermatoses | 21 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| evaluate the safety and tolerability of both formulations in the course of treatmen | 21 days of treatment |
Countries
Brazil
Outcome results
None listed