Efficacy Evaluation and Cutaneous Acceptability of the Lipikar Med Product on Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      In this study, we will test the tolerance of a topical product and its efficacy in reducing
      the atopy crisis duration and severity. The product will be tested alone, in children and
      adults with acute mild to moderate AD i.e as an alternative to alternative treatments, over 6
      weeks.
    

Detailed description: 
      Atopic dermatitis is a frequent chronic inflammatory skin disease affecting up to 20% of
      children and 8% of adults in developed countries. The disease is often localized with
      predilection for the face and limb folds but can be more widespread. AD is a chronic
      condition with many patterns of natural history the most frequent of which starting during
      infancy with spontaneous resolution after several years of an evolution characterized by
      alternance of flares and remissions. Other natural history profiles are also frequent and the
      disease is prevalent in adults as well, whether as a continuation of pediatric forms or as
      later onset diseases. Flares and remissions may as well altern in many different ways. AD is
      often associated with other atopic conditions including asthma, conjunctivitis and rhinitis5.
      Per se, the disease generates erythematous vesiculous plaques often associated with
      pruritis1. With time, lesion may become thicker (i.e. lichenified) and pruritus significantly
      impacts quality of life and sleep quality. The chronic and recurrent evolution is also felt
      as a burden by many patients and parents.

      Taking into account the various signs and symptoms (including itch and sleep disturbance),
      scores have been developed to properly assess severity and guide treatment, SCORAD being one
      of them used both in clinical practice and clinical research. Between flares, AD management
      aims at preventing recurrence by avoiding triggering factors and restoring skin barrier
      through daily application of emollients. During flares, topical steroids are more often used
      than calcineurin inhibitors mostly dedicated to sensitive areas (face, folds). More severe or
      resistant cases deserve phototherapy or systemic immunomodulatory treatments with many new
      drug candidates under clinical development. Back to topical treatments, many failures are due
      to improper usage of topical steroids because of corticophobia. As for calcineurin
      inhibitors, irritation is the main limiting factor10,11. This is where important room remains
      for new topical treatments with good safety and tolerance profiles leading to proper usage
      and good observance over time and avoiding as much as possible steroid application.
      Crisaborole has recently been authorized in the US and JAK inhibitors are currently under
      investigation which illustrates the actual need. AD pathophysiology is complex and its
      apprehension evolves over time. Current vision associates genetic background and
      environmental triggering factors. Three mains factors interact to generate AD namely 1) skin
      barrier defect, 2) skin inflammation driven by T lymphocytes and 3) dysbiosis through the
      decrease of skin microbiome diversity and staphylococcus proliferation. All three are deeply
      interlinked. Focusing on the latter, evidence is available that microbiome is disturbed
      during AD. Whether this dysbiosis is a cause or a consequence remains sometimes debated, but
      growing evidence suggests a causative relationship especially through S. aureus
      proliferation, at least as an aggravative factor. Indeed S. aureus is way more frequent on AD
      skin with good correlation with AD severity. Some of S aureus virulence factors
      (superantigens, enterotoxins, alphatoxins, proteases activators production) provide a good
      rational for it from a mechanistic standpoint. The decrease of the microbiome diversity, the
      role of which is to avoid pathogens proliferation, may play a role in S. aureus proliferation
      on AD skin, together with skin barrier and immune defect.

      Therefore, making available well tolerated and easy to use topical products avoiding S.
      aureus proliferation and dysbiosis fully makes sense whether as standalone or companion
      products both in flares management and prevention of recurrences.

      In this study, the sponsor will test a well tolerated topical product including a phage
      derived recombinant endolysine (Staphefekt®) with a capacity to specifically destroy S aureus
      regardless of its methicillin sensitivity. The product will be tested alone, in children and
      adults with acute mild to moderate AD i.e as an alternative to alternative treatments, over 6
      weeks.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study took place in Mauritius. Population comes from a database of subjects registered
        as suffering from DA. Further to facilitate recruitment, agents were appointed to look out
        for subjects presenting the required condition
      
Biospecimen description: 
      Skin microbial flora