Carbon Dioxide Nonablative Laser Compared with Topical Clobetasol for Lichen Sclerosus: A Randomized Controlled Trial.

OBJECTIVE

To compare nonablative carbon dioxide (CO 2 ) laser treatment with topical clobetasol propionate for symptom control in women with vulvar lichen sclerosus (LS).

METHODS

We conducted a prospective, randomized, open-label trial that included women with symptomatic LS. Participants were randomized to three courses of CO 2 laser treatment every 3 weeks or to a 3-month regimen of tapered topical clobetasol propionate 0.05%. The primary outcome was the change in the BIP (burn-itch-pain) score (range 0-30) from baseline to 3 months. Secondary outcomes included physician-rated visual improvement and overall improvement, and disease-specific quality of life (QOL). Ninety participants per group provided 90% power to detect a 2-point between-group BIP score difference (SD 4; 2-sided α=0.05). Analyses were intention-to-treat. Prespecified multivariable linear regression adjusted for baseline symptom severity, age, body mass index (BMI), smoking status, previous corticosteroid use, and disease duration.

RESULTS

Between November 2021 and March 2025, 245 women were randomized (laser: n=123; clobetasol propionate: n=122). At 3 months, symptom improvement was greater in the laser group (median ΔBIP score -8 [IQR -13 to-3]) than in the clobetasol propionate group (-5 [IQR, -10.75 to 0]; P =.007). In the multivariable analysis, laser treatment remained independently associated with greater symptom improvement (adjusted β, -2.90; 95% CI, -4.64 to -1.15; P =.001). Physician-rated visual improvement and overall improvement, and disease-specific QOL change favored laser therapy. Both treatments were generally well tolerated, with no serious treatment-related adverse events. During an exploratory postrandomization phase after the 3-month primary endpoint assessment, participants could choose to cross over to the alternative treatment. Patients who crossed over from clobetasol propionate to laser experienced additional symptom improvement from 3 to 6 months. Results were robust to sensitivity analyses for missing outcome data.

CONCLUSION

Laser treatment resulted in greater symptom improvement than clobetasol propionate therapy for women with vulvar LS. Sequential treatment with clobetasol propionate followed by CO 2 laser may further improve clinical symptoms.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT05010421.