Clobetasol Proprionate Versus Radiofrequency CO2 Laser for the Treatment of Lichen

2015-10-14 11:38:22 | BioPortfolio


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


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 radiofrequency 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 C02 radiofrequency laser therapy use in the vulva or vagina, although the treatment is widely accepted in plastic and cosmetic surgery and dermatology. Increased marketing for laser vaginal rejuvenation has spawned a proprietary female genital cosmetic surgery industry in the US with very limited published outcome data. SmartXide -V2-LR has some established outcome data for treatment of genitourinary syndrome of menopause GSM, also known as vulvovaginal atrophy (Salvatore).

The purpose of this study is to compare the safety and efficacy of clobetasol proprionate .05% ointment to radiofrequency CO2 laser procedure for the treatment of vulvar lichen sclerosus. Women presenting to the urogynecology clinic will be screened for lichen sclerosus. Vulvar biopsy will be performed for confirmation, and, if eligible, the patient will be consented to undergo baseline questionnaires, photodocumentation of vulvar lesions and randomization. A minimum of 2 weeks are required from the time of biopsy to treatment. Patient will be randomized to monthly LASER treatment for 3 months or topical STEROID therapy (clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) in a 1:1 ratio using a computer generated randomization schedule. Because of the nature of the treatment, it will not be possible to blind patients but the assessor will be blinded to the intervention.

Patient questionnaires include multiple validated scales and surveys to provided reproducible measures of vulvar symptoms as primary and secondary outcomes. Questionnaires will be completed at the intake visit, repeated at 12 weeks after treatment is completed or 26-28 weeks from intake, and one year follow up. The investigators expect improved subjective and objective results in the LASER group at 3 months compared with the STEROID group. Sample size calculations were conducted using the absolute change in the Skindex 29 as the primary end point. Out study will reach 80% power to detect a mean difference of 16 points on the Skindex 29 (sd=22 for both groups) between the study groups with 25 patients in each group, or 50 in total based on a one-sided two-sample t-test with alpha=0.05 (He). By accounting for 10% attrition, the investigators propose to recruit 56 patients to the study to be randomized with a 1:1 ratio to each group, with a blocked component for those who used tropical clobetasol in the past.

Data will be entered into a secure RedCAPS Database which provides complete auditing for data management processes. De-identified backup data will be kept in locked files at the participating site. Plans for publication will be handled by the investigators at MedStar Washington Hospital Center and will adhere to publication policies. All personnel with access to data collected have completed the Program for Ethics Education in Research training with the appropriate HIPAA certification.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Vulvar Lichen Sclerosus


Radiofrequency Carbon Dioxide Laser, Clobetasol Propionate 0.5% ointment


Medstar Washington Hospital Center
District of Columbia
United States




Medstar Research Institute

Results (where available)

View Results


Published on BioPortfolio: 2015-10-14T11:38:22-0400

Clinical Trials [1914 Associated Clinical Trials listed on BioPortfolio]

Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis

This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate...

A Psoriasis Plaque Test Comparing Products for the Treatment of Psoriasis Vulgaris

The purpose of this trial is to compare the anti-psoriatic effect of a topical combination product containing clobetasol propionate and calcipotriol in an ointment formulation to the singl...

A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam

The primary objective of this study is to evaluate the efficacy and safety of clobetasol propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.

Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.

A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspirati...

PubMed Articles [5850 Associated PubMed Articles listed on BioPortfolio]

Efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment in the treatment of mild to moderate psoriasis vulgaris: A randomized, single-blind, multicenter clinical trial.

To assess the efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment and calcipotriol/betamethasone dipropionate ointment in the treatment of mild-...

Rethinking the techno vagina: a case series of patient complications following vaginal laser treatment for atrophy.

The treatment of genitourinary syndrome of menopause (GSM) includes prescription hormone therapy, nonhormonal over-the-counter products, and most recently, laser treatment. Although the Food and Drug ...

Fractional Carbon Dioxide Laser in Patients with Skin Phototypes III to VI and Facial Burn Sequelae: 1-Year Follow-Up.

Fractional carbon dioxide laser treatment in postburn scars is safe and effective, but high rates of hypochromia (35 percent) have been described in patients with skin phototypes V and VI after 2 mont...

A Comparative Split-Face Trial of Plant-Based Hypoallergenic Ointment vs Petroleum-Based Ointment Following Fractionated Carbon Dioxide Laser Resurfacing of the Face

Purpose: Fractionated carbon dioxide (CO2) laser resurfacing uses fractional photothermolysis with an ablative 10,600-nm wavelength for treatment of rhytides and photodamage. Although associated with ...

Reliability of vulvar blood perfusion in women with provoked vestibulodynia using laser Doppler perfusion imaging and laser speckle imaging.

Microvascular assessment has become increasingly used in gynecology to better understand the pathophysiology of various vulvar conditions and to study sexual function. Alteration in blood perfusion of...

Medical and Biotech [MESH] Definitions

An enzyme with high affinity for carbon dioxide. It catalyzes irreversibly the formation of oxaloacetate from phosphoenolpyruvate and carbon dioxide. This fixation of carbon dioxide in several bacteria and some plants is the first step in the biosynthesis of glucose. EC

A family of zinc-containing enzymes that catalyze the reversible hydration of carbon dioxide. They play an important role in the transport of CARBON DIOXIDE from the tissues to the LUNG. EC

A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

Catalyzes the decarboxylation of an alpha keto acid to an aldehyde and carbon dioxide. Thiamine pyrophosphate is an essential cofactor. In lower organisms, which ferment glucose to ethanol and carbon dioxide, the enzyme irreversibly decarboxylates pyruvate to acetaldehyde. EC

A copper protein that catalyzes the formation of 2 moles of 3-phosphoglycerate from ribulose 1,5-biphosphate in the presence of carbon dioxide. It utilizes oxygen instead of carbon dioxide to form 2-phosphoglycollate and 3-phosphoglycerate. EC

More From BioPortfolio on "Clobetasol Proprionate Versus Radiofrequency CO2 Laser for the Treatment of Lichen"

Quick Search


Relevant Topics

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Searches Linking to this Trial