Back to resultsRandomized 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
Primary Purpose
Allergy, Dermatitis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dexamethasone + clemastine
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Allergy focused on measuring Allergic dermatitis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexamethasone + Clemastine
Dexamethasone
Arm Description
Dexamethasone + clemastine fumarate cream
Dexamethasone 0.5 mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of the efficacy.
Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01239719
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Azidus Brasil
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Dermatitis
Keywords
Allergic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone + Clemastine
Arm Type
Experimental
Arm Description
Dexamethasone + clemastine fumarate cream
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone 0.5 mg
Intervention Type
Drug
Intervention Name(s)
Dexamethasone + clemastine
Intervention Description
Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 0.5 mg: 01 tablet every 12 hours.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
14 days of treatment.
Secondary Outcome Measure Information:
Title
Evaluation of the efficacy.
Description
Constitute secondary signals of efficacy including excoriation, oozing, crusting and lichenification.
Time Frame
14 days of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Frederico, Physician
Phone
55 19 3829-3822
Email
alexandre@lalclinica.com.br
12. IPD Sharing Statement
Learn more about this trial
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
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