Trial Condition(s):

Dermatitis, Atopic

Functional study to investigate the efficacy of a new medical device (modified Diprobase formulation)

Bayer Identifier:

19689

ClinicalTrials.gov Identifier:

NCT03672383

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
42
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
BAY987534
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

proDerm

Hamburg, Germany, 22869

Status
Completed
 

Trial Design