Clinical trial NCT01125761: Efficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Dermatitis
Keywords: Allergic dermatitis
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 14 days
Secondary outcomes:
measure: Improvement of the erythema associated with allergic dermatitis.
timeFrame: 14 days
measure: Improvement of the edema associated with allergic dermatitis.
timeFrame: 14 days
measure: Improvement of the extension of lesion associated with allergic dermatitis.
timeFrame: 14 days
measure: Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis.
timeFrame: 14 days
measure: Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis.
timeFrame: 14 dyas
measure: Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis.
timeFrame: 14 days
measure: Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis.
timeFrame: 14 days
measure: Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment.
timeFrame: 14 days
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica Pesquisa e Desenvolvimento Ltda
state: São Paulo
city: Valinhos
country: Brazil
facility: LAL Clínica Pesquisa e Desenvolvimento Ltda
state: São Paulo
Study officials:
References: