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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 dermatitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Treatments: BB 1101; Clemastine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.