Efficacy and Safety of the Association of Dexamethasone 0.5 mg + Clemastine Fumarate 1 mg When Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis

Sponsor

Azidus Brasil (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01125761

Collaborator

(none)

104

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis	Drug: dexamethasone 0.5 mg and 1.0 mg clemastine cream Drug: Dexamethasone 0,5 mg cream	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2010

Anticipated Primary Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dexamethasone 0.5 mg and 1.0 mg clemastine cream	Drug: 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.
Active Comparator: dexamethasone 0,5 mg cream	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.

Arm

Intervention/Treatment

Experimental: dexamethasone 0.5 mg and 1.0 mg clemastine cream

Drug: 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.

Active Comparator: dexamethasone 0,5 mg cream

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis. [14 days]
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis. [14 days]
Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment. [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAL Clinica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo	Brazil	13276-245
2	LAL Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo	Brazil	13276-245