Status:
UNKNOWN
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
Lead Sponsor:
Azidus Brasil
Conditions:
Allergy
Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 dermatit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01239719
Start Date
March 1 2011
End Date
December 1 2011
Last Update
January 28 2011
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