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

Bayer1 site in 1 country42 target enrollmentSeptember 17, 2018

ConditionsDermatitis, Atopic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dermatitis, Atopic
Sponsor: Bayer
Enrollment: 42
Locations: 1
Primary Endpoint: AUC of the skin hydration assessed of treatment with the test product compared to untreated
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 17, 2018

End Date

October 17, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

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;

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;

Outcomes

Primary Outcomes

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 Outcomes

Transepidermal water loss(Up to 4 weeks)
Number of participants with adverse events (AEs)(Up to 4 weeks)
Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.)(Up to 4 weeks)
Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)(Up to 8 hours)
AUC of the short term skin hydration(Day 1)
Water gradient within stratum corneum assessed by Raman Spectrometry(Up to 8 hours)
Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)(Up to 4 weeks)
Skin pH(Up to 4 weeks)
Compliance check(Day 29)
Water content within stratum corneum assessed by Raman Spectrometry (unit: %)(Up to 8 hours)