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

NCT01125761 | Withdrawn Phase 3

• 1 other identifier: DECEMS21209
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Allergic dermatitis

Outcome Measures

Primary Outcomes (1)

• Through clinical examinations, evaluating the efficacy of the cream composed by 0.5 mg dexamethasone and clemastine 1mg compared with the cream of 0.5 mg dexamethasone in improving the signs and symptoms associated with allergic dermatitis.

  14 days

Secondary Outcomes (8)

• Improvement of the erythema associated with allergic dermatitis.

  14 days

• Improvement of the edema associated with allergic dermatitis.

  14 days

• Improvement of the extension of lesion associated with allergic dermatitis.

  14 days

• Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis.

  14 days

• Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis.

  14 dyas

Study Arms (2)

dexamethasone 0.5 mg and 1.0 mg clemastine cream

EXPERIMENTAL

Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream

dexamethasone 0,5 mg cream

ACTIVE COMPARATOR

Drug: Dexamethasone 0,5 mg cream

Interventions

dexamethasone 0.5 mg and 1.0 mg clemastine cream 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 and 1.0 mg clemastine cream

Dexamethasone 0,5 mg cream 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

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 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,

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (2)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13276-245, Brazil

Location

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13276-245, Brazil

Location

MeSH Terms

Conditions

Dermatitis; Dermatitis, Atopic

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

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; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. Alexandre Frederico

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

BR (2)