A Phase 3 interventional study of dexamethasone 0.5 mg and 1.0 mg clemastine cream and Dexamethasone 0,5 mg cream in Dermatitis, sponsored by Azidus Brasil. Withdrawn at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
Browse Dermatitis, Atopic studies →Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who sign the Deed of Consent (IC) in two ways, by his own free will, agreeing with all study procedures;
Exclusion Criteria:
Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream
Drug: Dexamethasone 0,5 mg cream
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.
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.
Time frame: 14 days
This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Azidus Brasil