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

NCT01239719 | Unknown Phase 3

• 2 other identifiers: DECEMS11209Version 02 - Amendment 02
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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

Keywords

Allergic dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the efficacy.

  14 days of treatment.

Study Arms (2)

Dexamethasone + Clemastine

EXPERIMENTAL

Dexamethasone + clemastine fumarate cream

Drug: Dexamethasone + clemastine

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 0.5 mg

Drug: Dexamethasone

Interventions

Dexamethasone + clemastine DRUG

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

Dexamethasone + Clemastine

Dexamethasone DRUG

Dexamethasone 0.5 mg: 01 tablet every 12 hours.

Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

MeSH Terms

Conditions

Hypersensitivity; Dermatitis; Dermatitis, Atopic

Interventions

clemastine, dexamethasone drug combination; Dexamethasone

Condition Hierarchy (Ancestors)

Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Eczematous; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Alexandre Frederico, Physician

CONTACT

55 19 3829-3822; alexandre@lalclinica.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: November 11, 2010
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 28, 2011

Record last verified: 2011-01