Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)

Study Overview
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Brief Summary
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This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.

Official Title
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Randomized, Controlled, Observer-blinded, Intra-individual Clinical Trial to Examine the Efficacy and Safety of a New Medical Device (Modified Diprobase Formulation) in Adults With Quiescent Atopic Dermatitis

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Device: BAY987534


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients being willing and able to provide written informed consent to participate in the study; Patients with self-reported history of AD (at least one flare up in the past with mild to moderate intensity), but with no flare-up within the last month; Patients aged between 18 - 65 years; Corneometer value < 35 a.u (on one volar forearm); Skin type I-IV (Fitzpatrick et al. 1974); Patients willing to adhere to trial procedures; Patients willing to discontinue the use of own cleansing and cosmetic products (e.g. soaps, creams, moisturizers) in test areas 3 days before Day 1 and throughout the course of the trial; Patients willing to stop smoking 2 hours before the instrumental measurements; Patients willing not to drink caffeinated beverages 2 hours before the instrumental measurements; Patients willing to avoid contact with water in the test areas 2 hours before the instrumental measurements; Negative urine pregnancy test (for female patients of child bearing potential); Women of child bearing potential have to use reliable methods of contraception with a low failure rate (i.e., less than 1 % per year; implants, injectables, combined oral contraceptives, hormone-based intrauterine-devices, sexual abstinence or vasectomized partner). Exclusion Criteria: Any other skin disease on the whole body that would interfere the clinical assessment in the opinion of the Investigator; Intake of drugs interfering with the immune system (e.g. corticosteroids, immunosuppressive drugs and antihistamines) within 30 days before screening as well as during the trial (with exception of routine vaccinations); Intrarectal or topical corticosteroids (in the test area) within 2 weeks before screening as well as during the trial; Known allergies to any of the ingredients of the test product; Any use of another topical emollient or other established treatment for atopic dermatitis in the test area; Any other adjuvant therapy for atopic dermatitis (UV therapy, probiotics homeopathy etc.); Patients with a Body Mass Index > 30; Diabetes mellitus; Patients who use tanning beds regularly within the past 2 years; Exposure of the test area to the sun; Pregnant or lactating women; Moles, tattoos, pigmentation or scars on the forearms that would influence the instrumental measurements; Hairy skin on test areas; Patients with psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing; Patients with any history of drug addiction or alcoholism in the past 3 years; Patients with expected poor compliance; Patients, who are inmates of psychiatric wards, prison or state institutions; Participation in a clinical trial with investigational medicinal products or medical devices within the last 30 days prior to the start of this trial; Patients underlying any other restrictions due to the participation in other tests / at other test institutes; Employees of the trial sites or of the Sponsor's company; Patients that according to the opinion of the Investigator should not participate in the trial for any reason.

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 |
| --- | --- |
| Experimental: BAY987534 (Treated Arm)<br>Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied. | Device: BAY987534<br>* Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .<br>* Other names: modified Diprobase formulation;|
| No Intervention: Untreated Arm<br>Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of the skin hydration assessed of treatment with the test product compared to untreated | AUC: Area under the curve | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of the short term skin hydration | Comparison of the test product to untreated | Day 1 | 
| Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.) | Comparison of the test product to untreated based on differences to Baseline as well as the comparison to Baseline | Up to 4 weeks | 
| Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.) | a.u.: arbitrary units | Up to 4 weeks | 
| Skin pH | Comparison of the test product to untreated based on the differences to Baseline | Up to 4 weeks | 
| Transepidermal water loss | Comparison of the test product to untreated based on differences to Baseline for SDS (Sodium dodecyl sulfate) unchallenged and SDS challenged skin | Up to 4 weeks | 
| Stratum corneum thickness assessed by Raman Spectrometry (unit: µm) | Comparison of the test product to untreated | Up to 8 hours | 
| Water gradient within stratum corneum assessed by Raman Spectrometry | Comparison of the test product to untreated | Up to 8 hours | 
| Number of participants with adverse events (AEs) |  | Up to 4 weeks | 
| Compliance check | The diaries will be collected and checked for compliance and completeness of the daily record | Day 29 | 
| Water content within stratum corneum assessed by Raman Spectrometry (unit: %) | Comparison of the test product to untreated | Up to 8 hours |