check_circleStudy Completed

Dermatitis, Atopic

Functional study to investigate the efficacy of a new medical device (modified Diprobase formulation)

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - 65 Years
  • - 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).
  • - 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.

Trial summary

Enrollment Goal
42
Trial Dates
September 2018 - October 2018
Phase
N/A
Could I Receive a placebo
No
Products
BAY987534
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
proDermHamburg, 22869, Germany

Primary Outcome

  • AUC of the skin hydration assessed of treatment with the test product compared to untreated
    AUC: Area under the curve
    date_rangeTime Frame:
    Up to 4 weeks

Secondary Outcome

  • AUC of the short term skin hydration
    Comparison of the test product to untreated
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Up to 4 weeks
  • Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.)
    a.u.: arbitrary units
    date_rangeTime Frame:
    Up to 4 weeks
  • Skin pH
    Comparison of the test product to untreated based on the differences to Baseline
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Up to 4 weeks
  • Stratum corneum thickness assessed by Raman Spectrometry (unit: µm)
    Comparison of the test product to untreated
    date_rangeTime Frame:
    Up to 8 hours
  • Water gradient within stratum corneum assessed by Raman Spectrometry
    Comparison of the test product to untreated
    date_rangeTime Frame:
    Up to 8 hours
  • Number of participants with adverse events (AEs)
    date_rangeTime Frame:
    Up to 4 weeks
  • Compliance check
    The diaries will be collected and checked for compliance and completeness of the daily record
    date_rangeTime Frame:
    Day 29
  • Water content within stratum corneum assessed by Raman Spectrometry (unit: %)
    Comparison of the test product to untreated
    date_rangeTime Frame:
    Up to 8 hours

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2