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

• ClinicalTrials.gov Identifier: NCT03672383
• Recruitment Status: Completed
• First Posted: September 14, 2018
• Last Update Posted: September 4, 2019
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dermatitis, Atopic	Device: BAY987534	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Observer-blind
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: September 17, 2018
• Actual Primary Completion Date: October 17, 2018
• Actual Study Completion Date: October 17, 2018

Arms and Interventions

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 Name: modified Diprobase formulation
No Intervention: Untreated Arm; Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied.

Outcome Measures

Primary Outcome Measures :

1. AUC of the skin hydration assessed of treatment with the test product compared to untreated [ Time Frame: Up to 4 weeks ]
   AUC: Area under the curve

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Germany

proDerm

Hamburg, Germany, 22869

Sponsors and Collaborators

Bayer

More Information

Additional Information:

Click here to find results for studies related to Bayer products 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03672383
• Other Study ID Numbers: 19689
• First Posted: September 14, 2018
• Last Update Posted: September 4, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases