Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
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|ClinicalTrials.gov Identifier: NCT01257061|
Recruitment Status : Unknown
Verified March 2013 by EMS.
Recruitment status was: Recruiting
First Posted : December 9, 2010
Last Update Posted : March 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Eczema||Drug: Group 1 Drug: Group 2||Phase 3|
• Double blinded, superiority, prospective parallel-group, intend to treat trial.
- Experiment duration: 22 days
- 2 visits (days 1,7,15 and 22)
- Reducing Eczema Area and severity index evaluation
- Adverse events evaluation
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Unicentric Comparing Effectiveness Superiority of to Clemastine Fumarate 1, 0 mg/g + Dexamethasone 0, 5 mg/g to Dexchlorpheniramine Maleate 10 mg/g in Eczema Treatment.|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||August 2013|
Experimental: Group 1
Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g
Drug: Group 1
Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion
Active Comparator: Group 2
Dexchlorpheniramine maleate 10 mg/g
Drug: Group 2
Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion
- Reduction / improvement of signs and symptoms [ Time Frame: DAY 22 ]The reduction of signs an symptoms will be evaluated by OSAAD index.
- Adverse Events Evaluation [ Time Frame: DAY 22 ]Adverse events will be collected and followed in order to evaluate safety and tolerability.
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): NCT01257061
|Contact: Flavia Addor||5511 3681 6362|
|Medcin instituto da Pele||Recruiting|
|Osasco, São Paulo, Brazil, 060323-000|
|Contact: Flavia Addor 5511 3681 6362|
|Principal Investigator:||Flavia Addor, MD||Medcin Instituto da Pele|
|Study Director:||Felipe Pinho, MD||EMS|