Functional study to investigate the efficacy of a new medical device (modified Diprobase formulation)
This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.
- 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).
- 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.
Hamburg, Germany, 22869
E-mail: [email protected]
Phone: (+)1-888-84 22937
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