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

Allergy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01239719
• Other study ID #: DECEMS11209
• Secondary ID: Version 02 - Ame
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 8, 2010
• Last updated: January 27, 2011
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2011
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: Alexandre Frederico, Physician
• Phone: 55 19 3829-3822
• Email: alexandre[@]lalclinica.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Dexamethasone + clemastine
Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
• Dexamethasone
Dexamethasone 0.5 mg: 01 tablet every 12 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	14 days of treatment.	No
Secondary	Evaluation of the efficacy.	Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.	14 days of treatment.	No