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Sponsors and Collaborators: |
Nycomed Nycomed US Inc. |
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Information provided by: | Nycomed |
ClinicalTrials.gov Identifier: | NCT00746382 |
The aim of this proof of concept study is to show the safety and efficacy of 0.5 % dermal roflumilast cream in the treatment of atopic dermatitis in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. 2-5 % of the body surface area (BSA) should be covered with a mild form of atopic dermatitis. In a 4-week treatment period 38 mg cream is applied two times daily on 0.5 to 1 % of the BSA. After a screening phase, a washout phase of flexible duration (max 30 days, time depending upon pre-medication), the 28 day treatment phase follows.As roflumilast is a potent antiinflammatory substance, a positive effect on this form of dermal disease is anticipated.
Condition | Intervention | Phase |
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Dermatitis |
Drug: Roflumilast cream Drug: Placebo cream |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis |
Estimated Enrollment: | 40 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Roflumilast cream 0.5%
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Drug: Roflumilast cream
Roflumilast cream 0.5% versus Placebo cream
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2: Placebo Comparator
Placebo cream
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Drug: Placebo cream
Placebo cream
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nycomed Exploratory Clinical Development | +497531840 | clinicaltrials@nycomed.com |
Study Chair: | Nycomed Exploratory Clinical Development | Headquarter |
Responsible Party: | Nycomed ( Exploratory Clinical Development ) |
Study ID Numbers: | RO-2351-001-EM |
Study First Received: | September 3, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00746382 |
Health Authority: | United States: Food and Drug Administration |
Mild atopic dermatitis, Roflumilast cream 0.5% |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Immune System Diseases |