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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY987534 (Treated Arm)	BAY987534	Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied.

Primary Outcome Measures

Name	Time	Method
AUC of the skin hydration assessed of treatment with the test product compared to untreated	Up to 4 weeks	AUC: Area under the curve

Secondary Outcome Measures

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

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

Recruitment & Eligibility

Study & Design

Trial Locations

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