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| ID | Type | Description | Link |
|---|---|---|---|
| Version 02 - Amendment 02 |
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The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone + Clemastine | Experimental | Dexamethasone + clemastine fumarate cream |
|
| Dexamethasone | Active Comparator | Dexamethasone 0.5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone + clemastine | Drug | Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate, through clinical examinations, the effectiveness of the combination tablet with 0.5 mg of dexamethasone and clemastine 1 mg, compared with 0.5 mg tablet of dexamethasone in improving the signs and symptoms associated with allergic dermatitis. | Evaluating the effectiveness of the polypill dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in improvement of signs (erythema, edema and lesion length) and symptoms (itching) associated with frames of dermatoses allergic. | 14 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the efficacy. | Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification. | 14 days of treatment. |
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Inclusion Criteria:
Patients who sign the IC in two ways, agreeing with all study procedures
Patients aged above 18 years of any ethnicity, class or social group, female or male
Patients with acute, subacute or chronic dermatoses, of inflammatory and / or allergic origin, to which it is recommended the use of drugs under investigation, such as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Frederico, Physician | Contact | 55 19 3829-3822 | alexandre@lalclinica.com.br |
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| Dexamethasone | Drug | Dexamethasone 0.5 mg: 01 tablet every 12 hours. |
|
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D003872 | Dermatitis |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| C015760 | clemastine, dexamethasone drug combination |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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