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
Overview
- Phase
- Phase 3
- Intervention
- Dexamethasone + clemastine
- Conditions
- Allergy
- Sponsor
- Azidus Brasil
- Enrollment
- 96
- Primary Endpoint
- 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.
- Last Updated
- 15 years ago
Overview
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 dermatitis.
Investigators
Eligibility 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
- •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
Arms & Interventions
Dexamethasone + Clemastine
Dexamethasone + clemastine fumarate cream
Intervention: Dexamethasone + clemastine
Dexamethasone
Dexamethasone 0.5 mg
Intervention: Dexamethasone
Outcomes
Primary Outcomes
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.
Time Frame: 14 days of treatment.
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.
Secondary Outcomes
- Evaluation of the efficacy.(14 days of treatment.)