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Tracking Information | |||||
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First Received Date † | September 3, 2008 | ||||
Last Updated Date | September 3, 2008 | ||||
Start Date † | November 2008 | ||||
Current Primary Outcome Measures † |
Improvement of clinical signs and symptoms score, improvement of patient judged pruritus severity [ Time Frame: 28 days ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
Improvement of atopic dermatitis severity score, change in dermal questionaire, safety and efficacy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM) | ||||
Official Title † | A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Dermatitis | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Not yet recruiting | ||||
Estimated Enrollment † | 40 | ||||
Estimated Completion Date | September 2009 | ||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00746382 | ||||
Responsible Party | Exploratory Clinical Development, Nycomed | ||||
Secondary IDs †† | |||||
Study Sponsor † | Nycomed | ||||
Collaborators †† | Nycomed US Inc. | ||||
Investigators † |
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Information Provided By | Nycomed | ||||
Verification Date | September 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |