Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis
|ClinicalTrials.gov Identifier: NCT01239719|
Recruitment Status : Unknown
Verified January 2011 by Azidus Brasil.
Recruitment status was: Not yet recruiting
First Posted : November 11, 2010
Last Update Posted : January 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Allergy Dermatitis||Drug: Dexamethasone + clemastine Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||December 2011|
Experimental: Dexamethasone + Clemastine
Dexamethasone + clemastine fumarate cream
Drug: Dexamethasone + clemastine
Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
Active Comparator: Dexamethasone
Dexamethasone 0.5 mg
Dexamethasone 0.5 mg: 01 tablet every 12 hours.
- 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. [ Time Frame: 14 days of treatment. ]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.
- Evaluation of the efficacy. [ Time Frame: 14 days of treatment. ]Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239719
|Contact: Alexandre Frederico, Physician||55 19 email@example.com|