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

January 27, 2011 updated by: Azidus Brasil
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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexamethasone + Clemastine
Dexamethasone + clemastine fumarate cream
Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
ACTIVE_COMPARATOR: Dexamethasone
Dexamethasone 0.5 mg
Dexamethasone 0.5 mg: 01 tablet every 12 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy.
Time Frame: 14 days of treatment.
Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.
14 days of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (ESTIMATE)

November 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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