Back to resultsEfficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis
Primary Purpose
Dermatitis
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
dexamethasone 0.5 mg and 1.0 mg clemastine cream
Dexamethasone 0,5 mg cream
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis focused on measuring Allergic dermatitis
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.
Sites / Locations
- LAL Clinica Pesquisa e Desenvolvimento Ltda
- LAL Clínica Pesquisa e Desenvolvimento Ltda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dexamethasone 0.5 mg and 1.0 mg clemastine cream
dexamethasone 0,5 mg cream
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Improvement of the erythema associated with allergic dermatitis.
Improvement of the edema associated with allergic dermatitis.
Improvement of the extension of lesion associated with allergic dermatitis.
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis.
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis.
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis.
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis.
Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01125761
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2010 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azidus Brasil
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis
Keywords
Allergic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexamethasone 0.5 mg and 1.0 mg clemastine cream
Arm Type
Experimental
Arm Title
dexamethasone 0,5 mg cream
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
dexamethasone 0.5 mg and 1.0 mg clemastine cream
Intervention Description
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 0,5 mg cream
Intervention Description
The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
Primary Outcome Measure Information:
Title
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Improvement of the erythema associated with allergic dermatitis.
Time Frame
14 days
Title
Improvement of the edema associated with allergic dermatitis.
Time Frame
14 days
Title
Improvement of the extension of lesion associated with allergic dermatitis.
Time Frame
14 days
Title
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing excoriation associated with allergic dermatitis.
Time Frame
14 days
Title
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing exudation associated with allergic dermatitis.
Time Frame
14 dyas
Title
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of scabbing associated with allergic dermatitis.
Time Frame
14 days
Title
Evaluate, through clinical examinations, the effectiveness of the drug association in reducing of lichenification associated with allergic dermatitis.
Time Frame
14 days
Title
Evaluate the safety of the formulations in relation to the occurrence, type, frequency and intensity of adverse events during treatment.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
LAL Clinica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
São Paulo
ZIP/Postal Code
13276-245
Country
Brazil
Facility Name
LAL Clínica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
São Paulo
ZIP/Postal Code
13276-245
Country
Brazil
12. IPD Sharing Statement
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Efficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis
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