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

This is an interventional treatment trial for Dermatitis, Atopic Read More

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.