Clinical Trial: Clobetasol Proprionate Versus Fractionated CO2 Laser for the Treatment of Lichen Sclerosus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Trial of Clobetasol Proprionate Versus Fractionated CO2 Laser for the Treatment of Lichen Sclerosus (CuRLS)

Brief Summary: This study is being done to compare the effects, good and bad, of fractionated CO2 laser treatment and clobetasol proprionate .05% ointment on vulvar lichen sclerosus.

Detailed Summary:

Vulvar lichen sclerosus (LS) is a well-characterized dermatosis resulting in labial atrophy, synechiae and introital narrowing and can often cause dyspareunia, itching and co-existent vulvar pain. Biopsy is necessary to confirm the clinical diagnosis and the mainstay of treatment usually consists of topical steroid therapy (Chi). Clobetasol proprionate and mometasone furoate are potent topical steroids that have long been considered gold-standard treatment for vulvar lichen sclerosus and work through anti-inflammatory, anti-mitotic, and immunosuppressive effects. One of the complications of long-term steroid use, however, is potential thinning of the vulvar skin, therefore limiting long-term use. Clobetasol proprionate has a range of efficacy from 61-91% depending on the selected outcome criteria.

The vulvovaginal SmartXide -V2-LR laser system by DEKA (Calezano, Italy) is a fractionated C02 laser with maximum 40 Watt power and laser energy emission at 10,600 nanometer wavelength which is mainly absorbed by water in the underlying tissue (Salvatore). The SmartXide-V2-LR system was first introduced in 2009 with DOT therapy distributing fractioned CO2 laser in small spots of 200 microns to the vulvar skin or vaginal epithelium, resulting in a portion of the skin remaining intact with less tissue destruction and faster healing (Salvatore). The device is cleared by the US Food and Drug Administration (FDA) for incision, excision, ablation, and coagulation of gynecologic soft tissues. The fractioned therapy has been shown to stimulate fibroblastic growth through activation and biosynthesis of collagen and restoration of the extracelluar matrix with collagen fibers.

Very little is known about long-term effects of fractionated C02 laser therapy use in the vulva or vagina, although the treatment is widely accepted in plastic and co
Sponsor: Medstar Health Research Institute

Current Primary Outcome: SkinDEX-29 Score [ Time Frame: Change from baseline score to score at six months ]

Validated subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus, described as a total numeric score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with adverse outcomes [ Time Frame: One year from treatment ]
    Total number with adverse outcomes to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment
  • Number of patients with adverse outcomes [ Time Frame: 6 months from treatment ]
    Total number with adverse outcomes to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment
  • Number of patients with adverse outcomes [ Time Frame: 12 weeks from treatment ]
    Total number with adverse outcomes to include description of pain, infection, de novo or worsening dyspareunia, contact dermatitis and burns from treatment
  • Subjective Vulvovaginal Symptoms Questionnaire (VSQ) [ Time Frame: One year from treatment ]
    Subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus
  • Health Related Quality of Life (HRQOL) Score [ Time Frame: Six months from treatment ]
    Patient global impression of improvement and satisfaction total score on visual analog scale
  • Health Related Quality of Life (HRQOL) Score [ Time Frame: 1 year from treatment ]
    Patient global impression of improvement and satisfaction total score on visual analog scale
  • Vaginal Health Index (VHI) Score [ Time Frame: Change from baseline to 6 months after treatment ]
    Provider scored objective appearance of vulvar Lichen Sclerosus total
  • Vaginal Health Index (VHI) Score [ Time Frame: Change from baseline to one year after treatment ]
    Provider scored objective appearance of vulvar Lichen Sclerosus total
  • Vulvar Lichen Sclerosus Photodocumentation [ Time Frame: Change from baseline to six month after treatment ]
    Visual objective comparison of Lichen Sclerosus
  • Vulvar Lichen Sclerosus Photodocumentation [ Time Frame: Change from baseline to one year after treatment ]
    Visual objective comparison of Lichen Sclerosus
  • Vulvar Symptom Visual Analog Scale (VAS) Score [ Time Frame: Change from baseline to 6 months after treatment ]
    Objective provider scale of visual appearance of Lichen Sclerosus total score
  • Vulvar Symptom Visual Analog Scale (VAS) Score [ Time Frame: Change from baseline to one year after treatment ]
    Objective provider scale of visual appearance of Lichen Sclerosus total score
  • SkinDEX-29 Score [ Time Frame: Change from baseline score to score at one year ]
    Validated subjective measure of vulvar symptoms of itching, burning, dyspareunia of Lichen Sclerosus, described as a total numeric score


Original Secondary Outcome: Same as current

Information By: Medstar Health Research Institute

Dates:
Date Received: October 7, 2015
Date Started: October 2015
Date Completion: April 2019
Last Updated: April 24, 2017
Last Verified: April 2017