NCT01257061

Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 5 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study design: • Double blinded, superiority, prospective parallel-group, intend to treat trial. Study design: * Experiment duration: 22 days * 2 visits (days 1,7,15 and 22) * Reducing Eczema Area and severity index evaluation * Adverse events evaluation

Conditions

• Eczema

Interventions

Type	Name	Description
DRUG	Group 1	Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion
DRUG	Group 2	Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion

Timeline

• Start date: 2012-09-06
• Primary completion: 2013-04-30
• Completion: 2013-08-02
• First posted: 2010-12-09
• Last updated: 2020-07-07

Locations

1 site across 1 country: Brazil