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

Sponsor

Azidus Brasil (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01239719

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergy Dermatitis	Drug: Dexamethasone + clemastine Drug: Dexamethasone	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone + Clemastine Dexamethasone + clemastine fumarate cream	Drug: Dexamethasone + clemastine Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
Active Comparator: Dexamethasone Dexamethasone 0.5 mg	Drug: Dexamethasone Dexamethasone 0.5 mg: 01 tablet every 12 hours.

Arm

Intervention/Treatment

Experimental: Dexamethasone + Clemastine

Dexamethasone + clemastine fumarate cream

Drug: Dexamethasone + clemastine

Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.

Active Comparator: Dexamethasone

Dexamethasone 0.5 mg

Drug: Dexamethasone

Dexamethasone 0.5 mg: 01 tablet every 12 hours.

Outcome Measures

Primary Outcome Measures

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. [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 Outcome Measures

Evaluation of the efficacy. [14 days of treatment.]
Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.