Obstetrics and gynecology · 2026
Carbon Dioxide Nonablative Laser Compared with Topical Clobetasol for Lichen Sclerosus: A Randomized Controlled Trial.
СтатьяНазвание и аннотация: Перевод в очереди
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Hecken Julia M, Shoham Ilana, Tempfer Clemens B, Rezniczek Günther A
Аннотация
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.
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.