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
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239719
|Contact: Alexandre Frederico, Physician||55 19 firstname.lastname@example.org|