Efficacy/Safety Study to Explore a New Revised Topical Formulation in Atopic Dermatitis

Study Overview
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Brief Summary
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The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.

Official Title
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An Investigator-blinded, Randomized, Monocentre, 3-arm, Pilot Trial to Compare the Efficacy and Safety of Two Topical Medical Devices in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With Untreated Skin

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Device: Phoenix II (BAY81-2996)
* Device: Phoenix I (BAY81-2996)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Caucasians aged between 18 and 60 years Patients with mild to moderate AD (Atopic Dermatitis) presenting a scoring AD (SCORAD) rating below 50 Skin type I - IV according to Fitzpatrick Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and </= 12) at Baseline Acute symptom of pruritus at Baseline Exclusion Criteria: Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment Regular intake of antiphlogistic drugs (for example, nonsteroidal anti-inflammatory drug [NSAIDs]) Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas) UV-therapy or the use of solarium within 30 days before screening as well as during the trial Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phoenix II<br>Application over 29 days twice daily | Device: Phoenix II (BAY81-2996)<br> <br> |
| Active Comparator: Phoenix I<br>Application over 29 days twice daily | Device: Phoenix I (BAY81-2996)<br> <br> |
| No Intervention: Untreated skin<br>Untreated skin areas of subjects will be observed over 29 days | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index |  | Up to 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with abnormal vital signs | Vital signs consist of blood pressure, heart rate, and body temperature | Up to 10 weeks | 
| Number of patients with adverse events as a measure of safety and tolerability |  | Up to 10 weeks | 
| Erythema by means of chromametry |  | Up to 29 days | 
| Transepidermal water loss (TEWL) as a measure for skin barrier function |  | Up to 29 days | 
| Skin hydration by means of corneometry |  | Up to 29 days | 
| Intensity of pruritus by means of visual analogue scale (VAS) |  | Up to 29 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phoenix, Mild atopic dermatitis, efficacy, safety