a study of safety and efficacy for an OTC skin rejuvenation device

• Research type

  Research Study

• Full title

  SKIN BEAUTY SkinRejuvTM System: a study of safety and efficacy for an over the counter (OTC) skin rejuvenation device

• IRAS ID

  181572

• Contact name

  Sarah Hackett

• Contact email

  shackett@shaser.com

• Duration of Study in the UK

  0 years, 6 months, 10 days

• Research summary

  The SKIN BEAUTY SkinRejuv(TM) System is a battery operated intense pulsed light (IPL) device. The intended use of the SKIN BEAUTY SkinRejuv(TM) System will be for skin rejuvenation of the face and chest, which includes treatment of freckles, sun spots, fine lines, dischromia, mottled complexion (skin tone), skin roughness (skin texture), and to reduce enlarged pore size.
  This study is intended to provide data on safety and effectiveness for an IPL device intended to be used for skin rejuvenation by women. The study will rely on visual assessment of improvement of aged and/or photo-damaged skin appearance via photographic analysis to meet endpoints. This study will rely on non-parametric procedures and inferential statistics using photographic analysis to establish efficacy. This study will use the Glogau Classification of Photoaging system to identify signs of aged and/or photo-damaged skin and will be a single site, non-randomized study enrolling only females.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  15/ES/0089

• Date of REC Opinion

  1 Jul 2015

• REC opinion

  Favourable Opinion