Eczema Clinical Trial
Official title:
Unicentric Comparing Effectiveness Superiority of to Clemastine Fumarate 1, 0 mg/g + Dexamethasone 0, 5 mg/g to Dexchlorpheniramine Maleate 10 mg/g in Eczema Treatment.
Verified date | June 2020 |
Source | EMS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.
Status | Completed |
Enrollment | 310 |
Est. completion date | August 2, 2013 |
Est. primary completion date | April 30, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Patients must be able to understand the study procedures agree to participate and give written consent. 2. Patients with acute or sub-acute eczema. 3. Presence of symmetric lesions to compare on side to the other. Exclusion Criteria: 1. Pregnancy or risk of pregnancy. 2. Lactation 3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study). 4. Sunlight over exposure in the last 15 days. 5. Any pathology or past medical condition that can interfere with this protocol. |
Country | Name | City | State |
---|---|---|---|
Brazil | Medcin instituto da Pele | Osasco | São Paulo |
Lead Sponsor | Collaborator |
---|---|
EMS |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction / improvement of signs and symptoms | The reduction of signs an symptoms will be evaluated by OSAAD index. | DAY 22 | |
Secondary | Adverse Events Evaluation | Adverse events will be collected and followed in order to evaluate safety and tolerability. | DAY 22 |
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