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Considering the pathogenesis of several allergic skin diseases to be investigated in this study as well as the pharmacodynamic mechanisms of the association of dexamethasone and clemastine fumarate, it is believed that the components of topical medication may act synergistically in the reduction of signs and symptoms of the diseases in question. Therefore it is expected that the association promotes results significantly superior to dexamethasone alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexamethasone 0.5 mg and 1.0 mg clemastine cream | Experimental |
| |
| dexamethasone 0,5 mg cream | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone 0.5 mg and 1.0 mg clemastine cream | Drug | The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Through clinical examinations, evaluating the efficacy of the cream composed by 0.5 mg dexamethasone and clemastine 1mg compared with the cream of 0.5 mg dexamethasone in improving the signs and symptoms associated with allergic dermatitis. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the erythema associated with allergic dermatitis. | 14 days | |
| Improvement of the edema associated with allergic dermatitis. | 14 days | |
| Improvement of the extension of lesion associated with allergic dermatitis. |
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Inclusion Criteria:
Patients who sign the Deed of Consent (IC) in two ways, by his own free will, agreeing with all study procedures;
atopic dermatitis,
prurigo,
primary contact dermatitis or allergic
urticaria,
pharmacodermic,
allergic vasculitis,
dyshidrosis,
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL Clinica Pesquisa e Desenvolvimento Ltda | Valinhos | São Paulo | 13276-245 | Brazil | ||
| LAL Clínica Pesquisa e Desenvolvimento Ltda |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone 0,5 mg cream | Drug | The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days. |
|
| 14 days |
| Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis. | 14 days |
| Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis. | 14 dyas |
| Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis. | 14 days |
| Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis. | 14 days |
| Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment. | 14 days |
| Valinhos |
| São Paulo |
| 13276-245 |
| Brazil |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |