Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus: A Randomized Controlled Trial

Abstract

Objective: To estimate the efficacy of fractionated carbon dioxide (CO2) laser therapy for vulvar lichen sclerosus.

Methods: We conducted a prospective, double-blind, randomized, sham-controlled, trial conducted in a clinic specializing in vulvar disorders. The study participants were 40 women with active vulvar lichen sclerosus confirmed with biopsy who were abstaining from topical and systemic treatments for at least 4 weeks before enrollment. Women were randomized in a 1:1 ratio to receive either five sham laser treatments or five fractionated CO2 treatments in a 24-week period. Study participants, treating clinicians, and the evaluating pathologist were blinded. The primary endpoint was the change in the histopathology scale score between pretreatment and posttreatment biopsies. We estimated 20 per group for 80% power to detect a 40% reduction in the histopathology scale score with up to 10% attrition. A secondary endpoint was the change in the validated CSS (Clinical Scoring System for Vulvar Lichen Sclerosus).

Results: From November 2018 to June 2020, 40 women were randomized to participate in the trial, and 37 women (19 fractionated CO2, 18 sham) were included in an intention-to-treat (ITT) analysis. Three women were excluded from the ITT analysis because they did not have posttreatment biopsies and, therefore, a posttreatment histopathology scale score could not be obtained. There was a 0.20 reduction (improvement) in histopathology scale score from baseline in the active treatment group (95% CI -1.1, 0.80, P=.74) and a 0.1 increase from baseline in the sham treatment group (95% CI -0.90, 1.0, P=.91). The change in histopathology scale score between the active and sham arm was not statistically significant (95% CI -1.14, 1.06, P=.76).

Conclusion: Fractionated CO2 is not an effective monotherapy treatment for vulvar lichen sclerosus.

Clinical trial registration: ClinicalTrials.gov, NCT03665584.

Funding source: Additional funding for this study was supplied by El.En Group, Florence, Italy, the manufacturer of the laser used in this study. In addition, El.En Group supplied the laser used in the study.

Conflict of interest statement

Financial Disclosure Andrew T. Goldstein disclosed that he is President of the Gynecologic Cancer Research Foundation, a 501(c)(3) non-profit corporation, which provided partial funding for this study. He is a part-time employee of Dare Bioscience. He has received research funding from Dare BIOScience, SST, Endoceutics, The Cellular Medicine Association, and Ipsen. He is a consultant for Ipsen, SST, and AMAG. Debra Heller received royalties for medical books, unrelated reimbursement/honorarium for giving CME talks at pathology meetings. Money was paid to her institution from the NIH and she received funds for medicolegal work. So Yeon Joyce Kong is an employee of Laerdal Medical, Stavanger, Norway. Maria Sophocles is on the speakers' bureau for Duchenay, DEKA, and Cynosure. The other authors did not report any potential conflicts of interest.

Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.

Figures

Fig. 1.. A study participant with the classic features of lichen sclerosus, including lichenification, hypopigmentation, ecchymosis, fissures, and scarring. The participant's right side has been treated with the fractionated CO2 laser, and the dots are visible.

Mitchell. Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus. Obstet Gynecol 2021.

Fig. 2.. CONSORT (Consolidated Standards of Reporting Trials) diagram.

Mitchell. Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus. Obstet Gynecol 2021.

Figure

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