Dermatitis, Atopic
Conditions
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.
Interventions
DEVICEBAY987534
Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Observer-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC of the skin hydration assessed of treatment with the test product compared to untreated | Up to 4 weeks | AUC: Area under the curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of the short term skin hydration | Day 1 | Comparison of the test product to untreated |
| Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.) | Up to 4 weeks | Comparison of the test product to untreated based on differences to Baseline as well as the comparison to Baseline |
| Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.) | Up to 4 weeks | a.u.: arbitrary units |
| Skin pH | Up to 4 weeks | Comparison of the test product to untreated based on the differences to Baseline |
| Water content within stratum corneum assessed by Raman Spectrometry (unit: %) | Up to 8 hours | Comparison of the test product to untreated |
| Stratum corneum thickness assessed by Raman Spectrometry (unit: µm) | Up to 8 hours | Comparison of the test product to untreated |
| Water gradient within stratum corneum assessed by Raman Spectrometry | Up to 8 hours | Comparison of the test product to untreated |
| Number of participants with adverse events (AEs) | Up to 4 weeks | — |
| Compliance check | Day 29 | The diaries will be collected and checked for compliance and completeness of the daily record |
| Transepidermal water loss | 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 |
Countries
Germany
Outcome results
None listed