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

Study Overview
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Brief Summary
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The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.

Conditions
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Allergy, Dermatitis

Intervention / Treatment
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* Drug: Dexamethasone + clemastine
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who sign the IC in two ways, agreeing with all study procedures Patients aged above 18 years of any ethnicity, class or social group, female or male Patients with acute, subacute or chronic dermatoses, of inflammatory and / or allergic origin, to which it is recommended the use of drugs under investigation, such as: atopic dermatitis prurigo primary contact dermatitis or allergic hives drug eruption allergic vasculitis dyshidrosis, Note: The above clinical conditions are diagnosed from clinical examination. Exclusion Criteria: Patients being treated with antibiotics Participation in clinical trials in the 12 months preceding the investigation Current treatment with immunosuppressants (eg, cyclosporine or methotrexate) Current treatment with phototherapy (UVA, UVB, PUVA and lasers) Use of systemic corticosteroids in the visit to include or 15 days preceding the survey Topical treatments at the site of lesions in the 15 days preceding the survey Presence of any skin condition Presence of secondary infections at the site of treatment, diagnosed clinically; Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckley's syndrome Pregnant or lactating women Chronic alcoholism Patients with a history of hypersensitivity to any component of the products under investigation. Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study. Allergic Dermatosis mild or, acording to the investigator criteria, is not justified systemic treatment.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone + Clemastine<br>Dexamethasone + clemastine fumarate cream | Drug: Dexamethasone + clemastine<br>* Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.<br>|
| Active Comparator: Dexamethasone<br>Dexamethasone 0.5 mg | Drug: Dexamethasone<br>* Dexamethasone 0.5 mg: 01 tablet every 12 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 14 days of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy. | Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification. | 14 days of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic dermatitis