MonaLisa Touch Laser for the Treatment of Vulvar Lichen Sclerosus
Lichen Sclerosus
About this trial
This is an interventional treatment trial for Lichen Sclerosus focused on measuring Lichen Sclerosus, MonaLisa Touch
Eligibility Criteria
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.
Sites / Locations
- The Centers for Vulvovaginal Disorders
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
FxCO2 Laser
Sham Laser
FxCO2 laser treatment will be performed by scanning across the entire affected anogenital region. The FxCO2 treatment will be performed at baseline and then repeated at 4 week intervals for a total of 5 treatments. The laser parameters change with each treatment: power (18, 20, 22, 24, 26W), dwell time (800, 900, 1000, 1000, 1000us) and spacing (1200, 1100, 1000, 1000, 1000um) in respective order.
Sham laser treatment will be performed by scanning across the entire affected anogenital region. The sham treatment will be performed using 4W (power), 400us (dwell time), and 1500um (spacing). The laser has no effect on the vulvar tissue using these parameters.