MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus

Lichen sclerosus (LS) is a chronic cutaneous disorder affecting approximately one in seventy
women. Presenting symptoms may include intense pruritus, pain, burning, and severe
dyspareunia. This disorder may affect any area of the skin, but has a notable predilection
for the anogenital skin. Extra-genital involvement is infrequent, affecting only 11% of women
with LS. Affected females outnumber affect males by 10:1. There is bimodal peak incidence in
premenarchal girls and menopausal women with an average age of onset of 51 years of age.

The typical lesions of LS are white plaques and papules, often with areas of ecchymosis,
excoriation, and ulceration. Often, there is destruction of the vulva architecture with
scarring of the clitoral prepuce, resorption of the labia minora, and narrowing of the
introitus. Four to six percent of women with LS will develop vulvar carcinoma. The
histopathologic changes of LS are distinctive and make biopsy a very useful diagnostic tool.
Characteristic pathologic finding include hyperkeratosis of the epidermis, epidermal atrophy
with loss of rete ridges, homogenization of the collagen in the upper dermis, and a lichenoid
(band-like) inflammatory infiltrate in the dermis. While there is no known cure for LS, the
current gold standard treatment is ultra-potent corticosteroids. When properly administered,
topical ultra-potent corticosteroids help to resolve the symptoms of pruritus and burning and
can prevent further vulvar scarring. In addition, proper treatment reverses the underlying
histopathologic changes of LS, and preliminary data shows that the risk of malignant
transformation also declines.

Although treatment with topical corticosteroids is effective, topical corticosteroids may
have serious local and systemic side effects, including dermal thinning, skin atrophy,
superimposed infections, rebound dermatitis, and adrenal insufficiency. Due to these side
effects, long- term use of corticosteroids for the treatment of vulvar lichen sclerosus may
be inadvisable. Therefore, a safe and effective alternative intervention is needed for this
disorder.

Recently, microablative fractional CO 2 laser (SmartXide 2 V 2 LR CO 2 laser system, for
MonaLisa Touch, DEKA, Florence, Italy) has been proposed for the management of LS. This type
of laser has a wavelength of 10,600 nm that allows a superficial microablative effect in soft
tissues and a pulsed beam that protects the tissues from possible overheating damage. The
laser beam is delivered to the tissue in a fractional manner, creating small spots (called
DOTs) alternating parts of tissue treated and not treated. The size of each DOT is set by the
manufacturer at 150 - 200 μm. Moreover, it has a DEKA pulse (D-pulse) mode that consists of
two parts: (a) constant, high energy peak power, for rapid superficial evaporation of the
atrophic epithelium with low water content and (b) lower peak power with longer emission
times that allows the energy heat to penetrate deeper in the epithelium. This D-pulse mode
combined with DOTs remodels the connective tissue via the production of heat shock protein 47
and produces new collagen/fibroblasts and ground matrix.

Recently, two small studies demonstrated that fractional CO 2 laser (FxCO 2 ) therapy appears
to be a promising treatment modality to treat lichen sclerosus. These studies demonstrated
that FxCO 2 treatment may stimulate protein synthesis, accelerate tissue reconstruction, and
decrease lichenification. Furthermore, after elimination of local inflammation, the stimulus
of nerve endings was reduced, so the clinical manifestations of LS, such as intense vulvar
pruritus and burning were improved.

Inclusion Criteria:

- Are 18 years or older.

- Have a diagnosis of active lichen sclerosus (Dr. Goldstein will remove a pea size
amount of skin (a biopsy) and will do a physical assessment of the vulva area at the
beginning of the study to confirm this diagnosis).

- Are willing and able to comply with the study requirements.

- Have a negative pregnancy test prior to enrolling in this study and will use at least
one form of birth control during the course of the study if you are sexually active
and are of child bearing potential.

- Have at least a 3 out of 10 on a questionnaire that measures the amount of itching you
are having.

Exclusion Criteria:

- Are immunocompromised (have a lowered immune system) (for example, you have been
diagnosed with or have a history of lymphoma, AIDS, or Wiskott-Aldrich Syndrome), or
have an uncontrolled malignant disease.

- Have a generalized infection (bacterial, viral or fungal), or obvious localized
infections in the vulva area.

- Have swollen lymph nodes (lymphadenopathy).

- Have any active sexually transmitted diseases on the vulva (herpes, molluscum,
condyloma).

- Have been diagnosed with other vulvar dermatologic conditions including lichen planus,
psoriasis, lichen simplex chronicus, candidiasis, intraepithelial neoplasia, or
carcinoma.

- Are pregnant or breastfeeding.

- If you become pregnant while on the study, you must withdraw from the study.

- Have received an investigational drug within four weeks prior to the study or who plan
to use other investigational drugs during the course of this study.

- Have severe medical condition(s) that in the view of the study doctor prohibits
participation in the study.

- Have a history of substance abuse or any factor, which limits your ability to
cooperate with the study procedures.

- Are uncooperative or are not willing to attend regular visits.

- Have received systemic immunosuppressants (steroids), other systemic therapies or any
other systemic therapies known or suspected to have an effect on vulvar lichen
sclerosus within 4 weeks prior to participation in the study.

- Have been treated with topical therapy (for example, topical corticosteroids,
pimecrolimus, tacrolimus) or any other topical therapies known or suspected to have an
effect on vulvar lichen sclerosus or its symptoms within 4 weeks prior to
participation in the study.