Allergy, Dermatitis
Conditions
Keywords
Allergic dermatitis
Brief summary
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.
Interventions
DRUGDexamethasone + clemastine
Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
DRUGDexamethasone
Dexamethasone 0.5 mg: 01 tablet every 12 hours.
Sponsors
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate, through clinical examinations, the effectiveness of the combination tablet with 0.5 mg of dexamethasone and clemastine 1 mg, compared with 0.5 mg tablet of dexamethasone in improving the signs and symptoms associated with allergic dermatitis. | 14 days of treatment. | Evaluating the effectiveness of the polypill dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in improvement of signs (erythema, edema and lesion length) and symptoms (itching) associated with frames of dermatoses allergic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy. | 14 days of treatment. | Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification. |
Contacts
Primary ContactAlexandre Frederico, Physician
Outcome results
None listed