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

Azidus

Status and phase: Unknown; Phase 3

Conditions: Dermatitis; Allergy

Treatments: Drug: Dexamethasone; Drug: Dexamethasone + clemastine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01239719

DECEMS11209

Version 02 - Amendment 02

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Dexamethasone + Clemastine

Experimental group

Description:

Dexamethasone + clemastine fumarate cream

Treatment:

Drug: Dexamethasone + clemastine

Dexamethasone

Active Comparator group

Description:

Dexamethasone 0.5 mg

Treatment:

Drug: Dexamethasone