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Skin tolerability
P.L.E.A.S.E.® - benefits
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Clinical study - human cutaneous tolerability study

Cutaneous tolerability of the P.L.E.A.S.E.® - device

Design of the study

  • 12 healthy volunteers Caucasian men and women, aged 18-50.
  • Application of 3-4 pore arrays of 150 pores each with a diameter of 200 µm and depths of 30, 60 and 90 µm with the PBS test laser
  • Pilot study partly single blinded (except occluded pore array, mono-centric)

Objective

  • Subjective assessment of discomfort (0= no, 1= slight, 2= moderate, 3= severe, 4= very severe discomfort)
  • Assessment of erythema and edema
  • Transepidermal water loss
  • Skin biopsies to assess thermal damage of the skin in three volunteers

Results

  • Discomfort: >90% no or slight discomfort (20% no, 70% slight)
  • Erythema, edema: slight redness that disappears after hours to a few days
  • Histological evaluation of biopsies shows no thermal damage of pore surrounding tissue


Green light for further Phase 1 studies, e.g. human bioavailability study with a selected drug intraepidermal system

 


Histological section taken from a skin biopsy (forearm)

 

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