A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)

Study Overview
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Brief Summary
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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.

Official Title
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A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis

Conditions
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Dermatitis

Intervention / Treatment
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* Drug: Roflumilast cream
* Drug: Placebo cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient /who is able to read, to write and to fully understand English language) has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure. Patients are suffering from mild, stable atopic dermatitis Male or female patient of any ethnic origin, age 18 years or older presenting a minimum of 2% to a maximum of 5% BSA affected by stable mild atopic dermatitis (IgE > 10)proven by a dermatologist. Patients must have at least one target lesion of at least 0.5% BSA. No evidence of oozing or crusting atopic dermatitis No lichenification of diseased lesions No excoriation of diseased lesions Patients must be willing to wash out from current active therapy for at least 14 days to Day 1. Women of childbearing potential must have a negative pregnancy test at the Screening and Baseline Visits and agree to use a highly effective method of birth control. A highly effective of birth control is defined at those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectable, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Exclusion Criteria: Patient has spontaneously improving or rapidly deteriorating atopic dermatitis. Patient has a physical condition which, in the Investigator´s opinion, might impair evaluation of atopic dermatitis or which exposes the patient to an unacceptable risk by study participation. Patient had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the Investigator likely to modify the patient´s disease. The patient had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 14 days prior to first application of study medication. Use of other topical preparations such as those containing vitamins, supplements or herbal within 14 days prior to application. Treatment with systemic/locally acting medications/procedures which might counter or influence the study aim within 30 days before the start and during the study /e.g. anti-histamines, topical glucocorticosteroids, pimecrolimus , tacrolimus systematic desensitization) Patient is pregnant, nursing or planning a pregnancy during the study period. Patient has received an investigational drug or an investigational device within 30 days prior to study start. Abuse of alcohol or drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Roflumilast cream 0.5% | Drug: Roflumilast cream<br>* Roflumilast cream 0.5% versus Placebo cream<br>|
| Placebo Comparator: 2<br>Placebo cream | Drug: Placebo cream<br>* Placebo cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of clinical signs and symptoms score, improvement of patient judged pruritus severity |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of atopic dermatitis severity score, change in dermal questionaire, safety and efficacy |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild atopic dermatitis, Roflumilast cream 0.5%