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Randomized Controlled Trial
. 2021 Jun 1;137(6):968-978.
doi: 10.1097/AOG.0000000000004332.

Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial

Linda S Burkett  1 , Moiuri Siddique, Alexander Zeymo, Elizabeth A Brunn, Robert E Gutman, Amy J Park, Cheryl B Iglesia
Affiliations
Randomized Controlled Trial

Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial

Linda S Burkett et al. Obstet Gynecol. .

Abstract

Objective: To compare 6-month safety and efficacy outcomes of fractionated CO2 laser (laser) with topical clobetasol propionate (steroid) for treatment of symptomatic vulvar lichen sclerosus.

Methods: We conducted a single-center randomized controlled trial that compared fractionated CO2 laser with steroid treatment for patients with biopsy-proven lichen sclerosus. Randomization was stratified by prior clobetasol propionate use. The primary outcome was mean change in Skindex-29 score at 6 months. A total sample size of 52 participants were recruited to detect a mean difference of 16 points on the Skindex-29 (SD±22) with 80% power, based on a one-sided two-sample t test with α=0.05, accounting for 10% attrition. Secondary outcomes included validated subjective and objective measures. Intention-to-treat, per protocol, and regression analysis based on prior steroid exposure were performed.

Results: From October 2015 to July 2018, 202 women were screened, 52 were randomized, and 51 completed a 6-month follow-up. No significant difference was found in baseline demographics, symptoms, and physician assessment scores. There was greater improvement in the Skindex-29 score in the laser arm at 6-months (10.9 point effect size, 95% CI 3.42-18.41; P=.007). Overall, 89% (23/27) of patients in the laser group rated symptoms as being "better or much better" compared with 62% (13/24) of patients in the steroid group, P=.07. More patients (81%, 21/27) were "satisfied or very satisfied" with laser treatment compared with steroid treatment (41%, 9/24); P=.01. After stratification for previous steroid use, the significant change of Skindex-29 score was only seen in the previously exposed group. There was one adverse event in each group: minor burning and blistering at the laser site and reactivation of genital herpes 1 week after starting steroid.

Conclusion: Fractionated CO2 laser treatment showed significant improvement in subjective symptoms and objective measures compared with clobetasol propionate, without serious safety or adverse events at 6 months.

Clinical trial registration: ClinicalTrials.gov, NCT02573883.

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Conflict of interest statement

Financial Disclosure Robert E. Gutman has received royalties from UpToDate, a research grant from Boston Scientific and SAB, and has been a J&J expert witness on a sling class-action lawsuit defense. Amy J. Park is a speaker for Allergan and receives honoraria from UpToDate. Cheryl B. Iglesia receives honorarium from UpToDate, is special government employee and consultant to USFDA ObGyn Devices panel 2011–2017, and served on five panels, now ad hoc, received research support from the Foundation for Female Health awareness, and National Vulvodynia Foundation made payable to MedStar Health Research Institute. The other authors did not report any potential conflicts of interest.

Comment in

References

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