A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 2% urea/20% glycerol cream; Miniderm® 20% cream; Diprobase® cream
Intervention description: Moisturizing cream for topical application; Moisturizing cream for topical application; Emollient cream for topical application
Intervention MeSH terms: Glycerol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Every patient use three different creams (1 test cream, 2 reference creams) and one untreated area. They are their own controls
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; skin barrier; moisturiser; emollient

Summary:

      Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease
      and it is characterised by exacerbations or relapses over years. The patients have a
      genetically impaired skin barrier that can be evaluated by measuring the transepidermal water
      loss (TEWL), which is increased in both dry skin and clinically normal skin in AD patients.
      Moisturisers are first line treatment for AD patients and moisturisers are the most
      prescribed products in dermatology. The use of moisturisers have been found to reduce the
      need for steroids.

      The newly developed moisturizing cream 1107.57 is intended for people with dry skin symptoms,
      such as dryness, itching, and flaking. As most people with dry skin of different origin have
      an impaired skin barrier function, it is important to investigate the possible influence on
      the skin barrier after long-term (several weeks') treatment. It is of utmost importance to
      evaluate different moisturisers head-to-head in order to facilitate an evidence-based choice
      of moisturiser.

      The primary objective of the trial is to determine whether applying the test cream 1107.57
      for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no
      treatment and (2) two reference creams in adults with a predisposition to a skin barrier
      defect. Secondary objectives are to determine whether there is a difference between 1107.57
      and (1) no treatment and (2) the two reference creams in skin moisturization, tolerability,
      cream consumption and safety.

      Participants will treat their lower volar forearms for 28 days with three different creams
      (test cream and two reference creams) and leave one area untreated as a control. Each forearm
      will have two different treatment areas and treatment allocation will be randomized. One
      Finger Tip Unit (FTU) of each cream will be applied twice daily on the designated study area
      for 28 days. On day 1 and 29 the transepidermal water loss (TEWL) and skin capacitance is
      measured on their forearms to evaluate the effect on skin barrier function and skin
      hydration. Furthermore, on day 31, after challenge with 1 % sodium lauryl sulphate (SLS) on
      day 29, the susceptibility to irritation caused by SLS will be evaluated visually and by
      measuring TEWL on their forearms. Study participants will attend visits at the start of
      randomised therapy and on day 5, 15, 29 and 31. During the study period the participants will
      also grade and evaluate the tolerability of the different creams.
    

Eligibility criteria:

        Inclusion Criteria:

        The participants have to meet all of the following criteria to be eligible to enter the
        study:

          -  Willing and able to provide informed consent

          -  Male or female and aged 18 years or above

          -  Volunteers able to read and understand English

          -  A personal history of atopic dermatitis

        Exclusion Criteria:

        Participants meeting any of the following criteria will not be permitted to enter the
        study:

          -  Eczema on the volar forearms requiring anti-inflammatory treatment

          -  Possible allergy to ingredients in the study medications.

          -  Any serious current medical condition which, in the opinion of the Investigator, may
             interfere with the evaluation of the results or may be contraindicated by the use of
             the test medications

          -  Use of any concomitant medication that may interfere with the study related activities
             or assessment of efficacy, as judged by the Investigator

          -  Use of any topical product, including cosmetic leave-on products on the volar
             forearms, within 1 week prior to, and throughout the study

          -  Female participant who, according to the participant, is pregnant or breast-feeding,
             or plans to become pregnant during the course of the study

          -  Any participant-related factor suggesting potential poor compliance with study
             procedures (e.g. psychiatric disorders, history of alcohol or substance abuse), as
             judged by the Investigator

          -  Enrolment in any interventional study or use of an investigational drug within 3
             months prior to the screening visit

          -  Volunteers judged by the PI to be inappropriate for the trial.