Efficacy test of a laser treatment device for skin rejuvenation

Laser Induced Optical Breakdown (LIOB) is a novel Philips proprietary
technology for skin rejuvenation that creates microscopic isolated damage areas
within tissue below epidermis level. This leads to a natural healing response
and consequently skin remodelling, resulting in skin rejuvenation effects. The
benefit of this technique is that it is a safe procedure potentially without
serious side effects and with high efficacy. In 2009, the effectiveness of the
prototype has been confirmed in both ex-vivo and in-vivo skin treatments (the
study with WMO registration number of M0-1953 titled *Skin response assessment
of a laser treatment device for skin rejuvenation). The efficacy of wrinkle and
fine line reduction has been proved in the pilot efficacy study in 2010 with
WMO registration number of M10-1011 titled *In-vivo pilot efficacy test of a
laser treatment device for skin rejuvenation*. In these in-vivo studies, it
reveals that skin has been microscopically damaged in dermal layer by laser
treatment and skin top layers, i.e. stratum corneum and epidermal layer, are
remained unaffected as expected indicating the treatment is rather safe. After
the treatment, new collagen formation was found from the histology work, and
reduction of wrinkles and fine lines was confirmed subjectively and
objectively. Additionally, the treatment was very acceptable by all test
subjects by scoring the pain sensation from *not perceptible* to *perceptible
but not painful*.
With this proposed study we want to achieve clinical relevance of the efficacy
for wrinkle and/or fine lines reduction on periorbital area, to evaluate
whether the sensation and side-effects experienced during skin treatment with
the prototype device are well accepted by test subjects

The primary objective is to achieve clinical relevance of the efficacy for the
purpose of wrinkle and/or fine line reduction on periorbital area. In addition,
to evaluate whether sensation and side effects experienced, e.g. sensation,
down-time, post-treatment effects etc, are accepted by test subjects.

This study is a randomized, split-face, non-blinded study.

Each subject will experience maximum 8 treatment sessions at the test site.
During the treatment session, the periorbital area with appearance of wrinkle
on one side of the face will be treated by the test researchers. Each treatment
session will take approximately 75 minutes. During the treatment session, the
subjects will be asked about their sensations. Subjects will likely experience
erythema and/or slight edema after treatment, which are defined as study
endpoints, and these, if any, will all be transient.
Risk for adverse skin responses, e.g. blistering, pigmentary changes, scarring,
is very low.
The benefit of this study is the potential improvement of wrinkle and/or fine
lines.