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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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RPCEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RPCEC00000001 |
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Date of registration:
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12/02/2009 |
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Primary sponsor: |
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Public title:
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Evaluation of the antiinflammatory effect of the Vimang® cream in patients with Dermatitis chronic disease.
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Scientific title:
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Evaluation of the antiinflammatory effect of the Vimang® cream in patients with Dermatitis chronic disease. |
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Date of first enrolment:
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18/03/2007 |
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Target sample size:
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30 |
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Recruitment status: |
Closed |
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URL:
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http://registroclinico.sld.cu/trials/RPCEC00000001-En |
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Study type:
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Interventional |
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Study design:
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Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Dr. Mariela
Guevara-Garcia |
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Address:
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21 Ave. and 200 St. Atabey, Playa
11600
Havana
Cuba |
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Telephone:
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(537)271 5067 |
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Email:
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marielaguevara@infomed.sld.cu |
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Affiliation:
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Center of Pharmaceutical Chemistry |
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Name:
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Dr. Mariela
Guevara-Garcia |
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Address:
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21 Ave. and 200 St., Atabey, Playa
11600
Havana
Cuba |
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Telephone:
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(537) 271 5067 |
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Email:
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marielaguevara@infomed.sld.cu |
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Affiliation:
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Center of Pharmaceutical Chemistry |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Pacients that sign the Informed Consent. 2. Patients with clinical and histological diagnosis of Dermatitis in chronic phase. The histologic study must be made at least 1 year before the inclusion. 3. Patients with extension of disease between the 2 and 30% of the affected corporal surface of agreement with the result obtained with the pattern of localization of the lesions. 4. Patients that could be receive ambulatory treatment.
Exclusion criteria: 1. Pregnancy, puerperal time or nursing. 2. Patients that have received another specific therapy for the Dermatitis during 10 previous days to the entrance in the study. 3. Patients with Dermatitis in acute phase or subacute. 4. Patients with steroid treatmemt. 5. Patients with illness chronic associate in acute phase(diabetes mellitus, renal chronic failure, hypertension, heart disease, severe psychiatric dysfunction or cancer) 6. Patients with acute severe infectious or in convalescence. 7. Patients with autoinmune diseases of any type. 8. The patient's negative to carry out protocolized studies. 9. Patients that are not corresponded the clinical study with the histological study
Age minimum:
18 years old
Age maximum:
60 years old
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dermatitis Chronic disease
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Intervention(s)
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They were formed two study groups. The study group received topical application with cream Vimang® 1.2%, three times to day during 6 weeks. The control group received topical application with the placebo cream in same dose and frequency.
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Primary Outcome(s)
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Clinical evaluation through the method DASI (Dermatitis Assay Score Index). DASI will be evaluated in the first consultation and to the 6 weeks.
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Secondary Outcome(s)
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It will be evaluated by interrogation and physical exam in weekly consultations during 6 weeks the presence of adverse effects: Pruritus Pain Ardor Blush Inflammation
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Source(s) of Monetary Support
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Ministry of Public Health and Ministry of Science, Technology and Environment.
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