functional study to investigate the efficacy of a new medical device (modified diprobase formulation)

Conditions: Dermatitis, Atopic

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


Eligibility criteria:
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.