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

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: Allergy; Dermatitis
• Intervention / Treatment: Drug: Dexamethasone + clemastine; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 3

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

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

Terms related to this study

• Keywords: Allergic dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Dexamethasone; Dexamethasone acetate; BB 1101; Clemastine
• Other Study ID Numbers: DECEMS11209; Version 02 - Amendment 02