Efficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis

NCT ID: NCT01125761

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2010-11-30

Brief Summary

Considering the pathogenesis of several allergic skin diseases to be investigated in this study as well as the pharmacodynamic mechanisms of the association of dexamethasone and clemastine fumarate, it is believed that the components of topical medication may act synergistically in the reduction of signs and symptoms of the diseases in question. Therefore it is expected that the association promotes results significantly superior to dexamethasone alone.

Conditions

Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

dexamethasone 0.5 mg and 1.0 mg clemastine cream

Group Type: EXPERIMENTAL

dexamethasone 0.5 mg and 1.0 mg clemastine cream

Intervention Type: DRUG

The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.

dexamethasone 0,5 mg cream

Group Type: ACTIVE_COMPARATOR

Dexamethasone 0,5 mg cream

Intervention Type: DRUG

The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.

Interventions

dexamethasone 0.5 mg and 1.0 mg clemastine cream

The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.

Intervention Type: DRUG

Dexamethasone 0,5 mg cream

The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who sign the Deed of Consent (IC) in two ways, by his own free will, agreeing with all study procedures;

• Patients older than 18 years, any ethnicity, class or social group, regardless of sex;
• Patients with pictures of dermatoses acute, subacute or chronic, of inflammatory origin and / or allergic, to which it is recommended the use of drugs under investigation topically, such as:
• atopic dermatitis,
• prurigo,
• primary contact dermatitis or allergic
• urticaria,
• pharmacodermic,
• allergic vasculitis,
• dyshidrosis,

Exclusion Criteria

• Patients being treated with antibiotics;
• Participation in clinical trials in the 12 months preceding the survey;
• Current treatment with immunosuppressants (eg, cyclosporine or methotrexate);
• Current treatment with phototherapy (UVA, UVB, PUVA and lasers);
• Use of systemic corticosteroids at inclusion visit or within 15 days prior to inclusion;
• Topical treatments at the site of acne in the 15 days preceding the visit of inclusion;
• Presence of any skin condition in areas affected by acne that hamper the evolutionary analysis of the lesion;
• Presence of secondary infections at the site of treatment, diagnosed clinically;
• Presence of other eczematous picture, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckley's syndrome Wiskott-Aldrich;
• Pregnant or lactating women;
• Chronic alcoholism;
• Patients with a history of hypersensitivity to any component of the formulas 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 of moderate or severe that, according to the investigator, is not justified topical.

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

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Azidus Brasil

Principal Investigator Dr. Alexandre Frederico

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DECEMS21209

Identifier Type: -

Identifier Source: org_study_id