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

Bayer

Status

Completed

Conditions

Dermatitis, Atopic

Treatments

Device: BAY987534

Study type

Interventional

Funder types

Industry

Identifiers

NCT03672383

19689

Details and patient eligibility

About

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

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.