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

Phase 3

• Conditions: Allergy; Dermatitis
• Interventions: Drug: Dexamethasone + clemastine; Drug: Dexamethasone

• Registration Number: NCT01239719
• Lead Sponsor: Azidus Brasil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-28
• Study Start: 2011-03
• Primary Completion: 2011-07
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone + Clemastine	Dexamethasone + clemastine	Dexamethasone + clemastine fumarate cream
Dexamethasone	Dexamethasone	Dexamethasone 0.5 mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evaluation of the efficacy.	14 days of treatment.	Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.