Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis
Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergy; Dermatitis
Intervention: Dexamethasone + clemastine (Drug); Dexamethasone (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda. Overall contact:
Alexandre Frederico, Physician, Phone: 55 19 3829-3822, Email: alexandre@lalclinica.com.br
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Evaluation of the efficacy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Alexandre Frederico, Physician, Phone: 55 19 3829-3822, Email: alexandre@lalclinica.com.br Additional Information
Starting date: March 2011
Last updated: January 27, 2011
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