Efficacy and Safety Evaluation of Splendor-X SMART System for hair removal, Prospective Multi Center Feasibility study, Within-Subject Controlled Treatment in healthy subjects.

Laser is the preferred hair removal method due to its superior speed, safety,
effectiveness and permanence. Destruction of the regenerative follicular
structures is a result of selectively absorbed light (in a specific wavelength,
pulse duration, and fluence) in the melanin within the hair shaft and follicle.
Therefore, the laser strength depends on the amount of melanin in the epidermis
of the skin: the darker the skin the higher the laser strength. However, if the
skin surrounding the follicle contains melanin, such as in tanned or dark
coloured skin, it may also absorb the photonic energy, resulting in skin
damage. To avoid skin damage, the Splendor-X has not only the alexandrite laser
at 755nm, successfully used to treat patients of skin phototypes I-IV, but also
the 1064nm Nd:YAG laser for treating tanned or darker skinned patients,
specifically those with skin phototype VI. Previous studies have shown that
multiplex treatments, sequentially using both wavelengths have a favourable
side effect profile when compared to single 755nm wavelength treatments.

Assessment of the human skin type is essential for optimal treatment and to
avoid damage. Human skin colour span from the darkest brown to the very light
hues. The skin colour can also vary within different areas in the same person
(e.g. front and back of the hand). Skin type recognition by eye differs
significantly from measured melanin level. When physicians are in doubt about
the skin type, spectrophotometers are used to measure melanin levels of the
skin separately from the laser treatment which significantly enhances accuracy.
Spectrophotometer-based assessment of skin type incorporated into the handpiece
and consequent automated calculation of the laser pre-set, implemented in the
laser system for each laser spot, is therefore the only precise way to
accurately adjust the laser parameters to the specific conditions of skin and
hair.

To improve the hair removal treatment of the Splendor-X, a new software using
artificial intelligence (AI) to determine the ideal laser parameters, is
developed. This software is implemented in the Splendor-X SMART, which is a
modified version of the CE and FDA proof Splendor-X. The approach to be studied
here is the feasibility of the advanced Splendor-X SMART to enable safe and
efficient hair removal treatment guided by artificial intelligence (AI).

Primary Objective: To study feasibility of a novel Splendor-X SMART system
platform for hair removal treatment for all skin types.
Secondary Objectives: To study efficacy and safety of the Splendor-X SMART
system for hair removal treatment for all skin types.

Multi-centre Feasibility study Within-Subject Controlled Treatment in healthy
subjects.

Within-subject randomization will assign standard treatment or Splendor X SMART
AI guided treatment to either left or right half of the anatomical area.

Risks
Eye injuries are possible to the operator and to any other entity (including
subjects) in treatment room. It should be entirely preventable by proper use of
dedicated eye shields, which will be worn by staff/ subjects in the presence of
laser irradiation. The laser room should undergo a Laser Safety Review to
ensure that local safety standards are followed. The laser rooms are already
used for routine laser treatments and are organized according to the Dutch
guidelines for Safe Use of Lasers (Laserveiligheid in de Gezondheidszorg, CJPM
Teirlinck en SR Vaartjes, Nederlandse Vereniging voor Klinische Fysica, 2015).
The potential risks for adverse effects of the treatment procedure include but
are not limited to hypo or hyper-pigmentation , Pain during treatment, Erythema
and edema immediately after treatment, it disappears in a few hours or a few
days at most , Crusts effect, Formation of blisters during the treatment, but
due to their intra-epidermal nature, they usually heal without producing scars,
Scar effect or Poor clinical response, itching, tingling or burning sensation
(during or immediately following treatment which might last up to several
days), inflammation (caused by possible skin irritation from the shaving/
treatment), development erythema ab igne, a temporary increase in hair growth
in the treated area, bruising or a purple discoloration of the treated area
(might last for several days), skin burn, infection (infection in the hair
follicle/ viral infection).
As detailed above in the Anticipated Adverse Events section. In the case of an
infection evolving in the treated area the subject will be provided antibiotics
for the treatment of the infection at no cost.
The analyzed safety requirements are considered by the manufacturer as fully
mitigated to an acceptable risk level per the standard requirements.
A complementary risk analysis has been performed to assess the possible
additional risks related to the modifications that were introduce to the
investigational device for the purpose of this study. It has been determined
that no additional risks were introduced and all residual risk are considered
acceptable.

Benefits
Potential benefits may include but are not limited to temporary hair removal,
permanent hair reduction.