Evaluation of the ReAura skin rejuvenation device for daily self-administred full face treatment of fine lines

Fractional photothermolyis is a skin rejuvenation treatment which thermally
creates tiny damaged areas within tissue. This leads to a natural healing
response and skin remodelling. The big advantage of this treatment is that it
is a safe procedure without many side effects, but with high efficacy. Palovia
(Palomar) is the first over-the-counter skin rejuvenation device with this
technology, cleared by FDA, which has been launched in 2011. Philips will soon
introduce the ReAuratm Skin Rejuvenation Device. ReAuratm is a handheld, low
intensity skin rejuvenation device for self-administered treatment at home
which is intended to be used twice weekly during a 8-12 weeks period. In this
study we want to investigate the efficacy and safety of a new daily treatment
regimen with ReAuratm. This is to determine if the new regimen is more
effective for skin rejuvenation than the prescribed regimen used at this
moment. The data is expected to be used in support of the 510(k) for evaluation
of the ReAuratm Skin Rejuvenation Device for over-the-counter use.

The primary objective is to evaluate the effectiveness and safety of the new
user regimen for the reduction of fine lines in the face. In addition, the
effectiveness for improvement in skin texture, overall appearance, skin tone,
radiance, and the safe usage of the investigational device will be evaluated.
It is expected that the new user regimen will result in an improvement of at
least 1 point on the Fitzpatrick Wrinkle Scale in at least 60% of the subjects
at 1 week after completion of the 30 day treatment regimen.

This study is a non-blinded partly home based, partly in-clinic study. This
trial is executed in Eindhoven, The Netherlands.

All subjects will treat the face with RéAuratm, a handheld, laser-based, skin
rejuvenation device, during 30 daily sessions and additionally bi weekly during
two months of maintenance. Per treatment 2 laser-doses will be applied full
face.

The subjects have to perform daily treatments for 30 consecutive days.
Hereafter, the subjects will perform two treatments a week during two months.
Furthermore, they have to come 11 times to the test facilities for photography,
video recording, questionnaires and a self-administered treatment. Visits will
take up to 1 hour; the treatments at home are estimated at 15 minutes, in which
the subjects will self-treat their face. Subjects will experience some
erythema, heat sensation and possibly slight edema after treatment, but these
will all be transient. Risk for side effects is low. Possible side effects
include inflammation, hyperpigmentation, cold sores, reactivation of herpes
simplex virus, acne or eczema flare-up and allergic reactions to the laser
performance gel or aftercare complex. The benefit for the subjects is expected
to be a skin rejuvenation effect which may include improvement in fine lines,
texture, skin tone, radiance and overall appearance. Response to the treatment
is individual and it is possible that in some subjects no significant
improvement will be observed.