CO2 Laser Monotherapy of Questionable Efficacy in Vulvar Lichen Sclerosus

By David Douglas

May 27, 2021

NEW YORK (Reuters Health) - Patients with vulvar lichen sclerosus who undergo fractionated CO2 laser treatment appear more satisfied than those given topical clobetasol propionate, according to a new randomized study. However, the researchers behind another trial conclude the laser approach is not an effective monotherapy.

The skin condition often leads to itching, vulvar pain and dyspareunia. It is also associated with an increased risk of vulvar squamous-cell carcinoma.

Clobetasol propionate has long been considered the standard treatment and works via anti-inflammatory, antimitotic and immunosuppressive effects. Symptomatic improvement may reach 66% to 96%, with complete remission of up to 23% to 54%, but many patients "are not adequately treated owing to inconsistent prescribing practices or patient intolerance," Dr. Linda S. Burkett of the University of Pittsburgh Health System and colleagues write in one of the new papers, both published in Obstetrics and Gynecology.

Thus, she told Reuters Health by email, "there may be a place for new treatment options in lichen sclerosus." Her team notes that according to case reports, use of fractionated CO2 laser in addition to topical clobetasol propionate has led to the improvement of symptoms in the majority of patients, with no disease progression.

To investigate whether the laser treatment alone could replace steroid therapy, they studied 52 patients with biopsy-proven vulvar lichen sclerosus. Following an eight-week washout period for those who had been using clobetasol propionate or other topical or systemic immunomodulators, participants were randomized to three office laser treatments four to six weeks apart or prescriptions for clobetasol propionate 0.05% ointment.

At six months there was greater improvement in the Skindex-29 score in the laser arm (10.9-point effect size; P=0.007), and 89% of this group rated symptoms as being “better or much better” compared to 62% of patients in the steroid group (P=0.07).

However, after stratification for previous steroid use, significant change in the overall Skindex-29 score was seen only in the previously exposed group. More steroid patients (25%) were oncompliant compared to 4% of the laser group.

"Subjects had greater symptomatic and visual improvement after six months in the fractionated laser arm versus clobetasol," Dr. Burkett said. "We hope to see other research and that clinicians will also explore this treatment option so that we can work to improve the health of women with vulvar lichen sclerosus."

In the other study, a double-blind, randomized, sham-controlled trial, Dr. Jill M. Krapf of the Centers for Vulvovaginal Disorders, in Washington, D.C., and colleagues concluded that the laser approach alone was not effective, however.

The team studied 40 women who underwent either five sham laser treatments or five fractionated CO2 laser treatments over a 24-week period.

"The change in histopathology scale score between the active and sham arm was not statistically significant," the researchers report.

Dr. Krapf told Reuters Health by email, "Treatments that only improve symptoms, without reversing the underlying tissue histopathology, do not change the progression of the disease and are therefore inadequate. The results of this study indicate that fractionated CO2 laser alone does not improve histopathologic inflammation, unlike the current gold-standard treatment of ultrapotent topical corticosteroids."

Dr. Krapf concluded , "There is a very strong placebo effect demonstrated in this type of study, which underscores the need for future studies on experimental energy-based treatments to include a sham-placebo arm and histopathologic changes as a primary endpoint."

In an accompanying editorial, Dr. Melissa M. Mauskar of the University of Texas Southwestern Medical Center, in Dallas, notes that validated scoring systems were used in both studies, but each group used a different scoring system and multiple physicians rated disease activity.

"Unfortunately," she points out, "to date, we do not have a validated clinical scoring system for vulvar lichen sclerosus with high interrater reliability."

"On the surface, fractionated CO2 laser appears to provide symptomatic improvement for patients; however, given the considerable placebo effect, lack of histologic improvement, posttreatment photographs, and significant out-of-pocket cost for patients, this treatment will not replace ultrapotent topical steroids as first-line therapy for vulvar lichen sclerosus in my practice," Dr. Mauskar concludes.

SOURCE: https://bit.ly/3oSxEJ1, https://bit.ly/2QRP2kI and https://bit.ly/3hXOi8V Obstetrics and Gynecology, online May 6, 2021.

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