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

NCT ID: NCT01239719

Last Updated: 2011-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-12-31

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.

Conditions

Allergy; Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexamethasone + Clemastine

Dexamethasone + clemastine fumarate cream

Group Type: EXPERIMENTAL

Dexamethasone + clemastine

Intervention Type: DRUG

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

Dexamethasone

Dexamethasone 0.5 mg

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Dexamethasone 0.5 mg: 01 tablet every 12 hours.

Interventions

Dexamethasone + clemastine

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

Intervention Type: DRUG

Dexamethasone

Dexamethasone 0.5 mg: 01 tablet every 12 hours.

Intervention Type: DRUG

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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clínica

Central Contacts

Alexandre Frederico, Physician

Role: CONTACT

alexandre@lalclinica.com.br

55 19 3829-3822

Other Identifiers

Version 02 - Amendment 02

Identifier Type: -

Identifier Source: secondary_id

DECEMS11209

Identifier Type: -

Identifier Source: org_study_id