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

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

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

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Device: BAY987534

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22869
    • proDerm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAY987534 (Treated Arm); Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied.	Device: BAY987534; Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .; Other Names: modified Diprobase formulation
No Intervention: Untreated Arm; Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of the skin hydration assessed of treatment with the test product compared to untreated	AUC: Area under the curve	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)		Up to 4 weeks
AUC of the short term skin hydration	Comparison of the test product to untreated	Day 1
Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.)	Comparison of the test product to untreated based on differences to Baseline as well as the comparison to Baseline	Up to 4 weeks
Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)	a.u.: arbitrary units	Up to 4 weeks
Skin pH	Comparison of the test product to untreated based on the differences to Baseline	Up to 4 weeks
Transepidermal water loss	Comparison of the test product to untreated based on differences to Baseline for SDS (Sodium dodecyl sulfate) unchallenged and SDS challenged skin	Up to 4 weeks
Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)	Comparison of the test product to untreated	Up to 8 hours
Water gradient within stratum corneum assessed by Raman Spectrometry	Comparison of the test product to untreated	Up to 8 hours
Compliance check	The diaries will be collected and checked for compliance and completeness of the daily record	Day 29
Water content within stratum corneum assessed by Raman Spectrometry (unit: %)	Comparison of the test product to untreated	Up to 8 hours

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): October 17, 2018
• Study Completion (Actual): October 17, 2018

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: 19689

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No