Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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.|
- Reduction / improvement of signs and symptoms [ Time Frame: DAY 22 ] [ Designated as safety issue: No ]The reduction of signs an symptoms will be evaluated by OSAAD index.
- Adverse Events Evaluation [ Time Frame: DAY 22 ] [ Designated as safety issue: Yes ]Adverse events will be collected and followed in order to evaluate safety and tolerability.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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
• 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
Please refer to this study by its ClinicalTrials.gov identifier: 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|