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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Eczema

Intervention / Treatment
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* Drug: Group 1
* Drug: Group 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be able to understand the study procedures agree to participate and give written consent. Patients with acute or sub-acute eczema. Presence of symmetric lesions to compare on side to the other. Exclusion Criteria: Pregnancy or risk of pregnancy. Lactation Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study). Sunlight over exposure in the last 15 days. Any pathology or past medical condition that can interfere with this protocol.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g | Drug: Group 1<br>* Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion<br>|
| Active Comparator: Group 2<br>Dexchlorpheniramine maleate 10 mg/g | Drug: Group 2<br>* Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction / improvement of signs and symptoms | The reduction of signs an symptoms will be evaluated by OSAAD index. | DAY 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events Evaluation | Adverse events will be collected and followed in order to evaluate safety and tolerability. | DAY 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Dermatitis, Atopic