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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
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.
Time frame: 14 days
Improvement of the erythema associated with allergic dermatitis.
Time frame: 14 days
Improvement of the edema associated with allergic dermatitis.
Time frame: 14 days
Improvement of the extension of lesion associated with allergic dermatitis.
Time frame: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis.
Time frame: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis.
Time frame: 14 dyas
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis.
Time frame: 14 days
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis.
Time frame: 14 days
Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment.
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Time frame: 14 days