an OTC skin rejuvenation corded device: a study of safety and efficacy
Research type
Research Study
Full title
ARLINGTON SkinRejuv™ System: A Study of Safety and Efficacy for an over the counter (OTC) Skin Rejuvenation Device
IRAS ID
216357
Contact name
James Ferguson
Contact email
Sponsor organisation
Shaser, Inc
Duration of Study in the UK
0 years, 11 months, 6 days
Research summary
The Shaser ARLINGTON SkinRejuv™ System is an intense pulsed light (IPL) device that is similar to that of the SKIN BEAUTY SkinRejuv™ System. The intended use of the Shaser ARLINGTON SkinRejuv™ System will be for ‘skin rejuvenation of the face and chest, which includes treatment of freckles, sun spots, fine lines, dyschromia, mottled complexion (skin tone), skin roughness (skin texture), redness, broken capillaries, 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 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
16/ES/0129
Date of REC Opinion
21 Nov 2016
REC opinion
Further Information Favourable Opinion