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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Clotrimazole + Gentamicin + Beclomethasone | Experimental |
| |
| Treatment with Clotrimazole + Gentamicin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clotrimazole + Gentamicin + Beclomethasone | Drug | Treatment with Clotrimazole + Gentamicin + Beclomethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the treatment in patient with infected dermatoses | 21 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the safety and tolerability of both formulations in the course of treatmen | 21 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Frederico, médico | Azidus Brasil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL Clinica | Valinhos | São Paulo | 13276245 | Brazil |
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| ID | Term |
|---|---|
| D005499 | Folliculitis |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003022 | Clotrimazole |
| D005839 | Gentamicins |
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Clotrimazole + Gentamicin | Drug | Treatment with Clotrimazole + Gentamicin |
|
| D000617 |
| Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |