Skin bioMARkers for Atopic Eczema Therapy Evaluation
Condition: Atopic Eczema/Dermatitis (Non-Specific)
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to investigate two new non-invasive technologies for assessing skin properties
      to identify and validate a range of safety biomarkers that may be considered useful as
      primary outcome measures for evaluating the safety of topical treatments in atopic
      dermatitis. The method of assessing these biomarker technologies will be to determine whether
      twice daily treatment with crisaborole (2%) ointment, compared to betamethasone valerate
      (0.1%) cream, for up to 4 weeks, may cause skin structure or function changes, like skin
      atrophy, in patients with atopic dermatitis (AD).
    

Detailed description: 
      The first-line drug treatment for mild-moderate AD are currently topical corticosteroids
      (TCS) with recognized efficacy. However, their prolonged or inappropriate use, can lead to
      local adverse effects. Side-effects of topical corticosteroids comprise a variety of skin
      changes in the sense of skin atrophy thinning of the skin and in some cases development of
      telangiectasia, spontaneous scars, folliculitis, striae distensae (stretch marks), contact
      dermatitis, acne or rosacea depending on potency, galenic formulation, patient age and body
      area to which the medication will be applied, exposure time.

      Assessing the safety (local adverse effects) of current or new treatments and new treatment
      approaches using existing treatments through noninvasively monitor on possible early skin
      (subclinical) changes associated with the local clinical adverse effects of treatment may be
      an effective step for an enhanced AD treatment management.

      Primary Aim: To further develop and validate two new non-invasive technologies for the
      assessment of early sub-clinical skin changes associated with adverse effects and to derive
      an optimum panel of safety biomarkers for use in future clinical trials of topical
      anti-inflammatory treatments.

      The safety of two topical anti-inflammatory treatments for AD will be compared in this
      clinical trial, with a focus on early sub-clinical signs: crisaborole 2% ointment and
      betamethasone valerate 0,1% cream. Step 1 involves the collection of data on the early
      sub-clinical skin changes using the non-invasive technologies: OCT and FTIR spectroscopy. The
      data from this study will then be used to identify and refine biophysical biomarkers of skin
      atrophy and skin barrier disruption in steps 2 and 3.

      Secondary Aim: To determine the relative local skin effects of crisaborole (2%) ointment
      compared to a potent and moderately potent TCS in participants with mild to moderate AD. The
      focus is on 'early biomarkers' of 'local skin changes'and not clinical efficacy, which has
      been established in previous trials.

      Rationale for selecting the two comparators are related to prescription behaviors in UK
      (Betamethasone valerate 0,1% cream) and with no reported TCS-like local adverse effects
      profile (crisaborole 2% ointment)
    

Intervention name(s): crisaborole (2%) ointment; betamethasone valerate 0.1% cream
Intervention type(s): Drug; Drug
Intervention description(s): twice daily application on one forearm for 4 weeks (randomised site allocation); twice daily application on one forearm for 4 weeks (randomised site allocation)
Other intervention name(s): Eucrisa; Betnovate cream
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Intervention model: Single Group Assignment
Intervention model description: An observer-blind forearm-controlled clinical trial in 37 AD patients, wherein each participant will undergo 4 weeks treatment with crisaborole (2%) ointment on one forearm and betamethasone valerate (0.1%) cream on the other (twice daily application in each case and randomised site allocation). At the start of the study the skin of the test sites (forearms) will be clear of the signs of AD so that the investigation focuses on local adverse effects on the skin as opposed to anti-inflammatory effects (focus on local adverse effects and not clinical efficacy). The condition of the skin will be assessed before, during and after treatment.
Masking: None (Open Label)
Primary purpose: Other