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

NCT ID: NCT03672383

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2018-10-17

Brief 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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BAY987534 (Treated Arm)

Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied.

Group Type: EXPERIMENTAL

BAY987534

Intervention Type: DEVICE

Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .

Untreated Arm

Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BAY987534

Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .

Intervention Type: DEVICE

Other Intervention Names

modified Diprobase formulation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

proDerm

Hamburg, , Germany

Countries

Germany

Related Links

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

19689

Identifier Type: -

Identifier Source: org_study_id