Trial reportArchives of gynecology and obstetrics2026
One-year outcome after laser treatment of vulvar lichen sclerosus: a prospective observational trial.
Trial report in Archives of gynecology and obstetrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03926299 (Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd:YAG/Er:YAG Dual Laser Therapy is Effective to Treat Vulvar Lichen Sclerosus and Similar to Standard Treatment With Steroid Cream
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Authors and funding
4 authors.
Funding
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Abstract
purposeTo assess the 12-month efficacy of a novel non-ablative dual Nd:YAG/Er:YAG laser therapy for vulvar lichen sclerosus (LS) and to evaluate the impact of crossover laser treatment following initial topical corticosteroid therapy.
methodsThis study presents the 1-year data of a prospective observational trial. Between baseline and 6 months, women with vulvar LS were randomized to receive either dual Nd:YAG/Er:YAG laser therapy or topical clobetasol propionate. Between 6 and 12 months, optional steroid or laser therapies were offered.
resultsIn the laser group, 34 of 44 patients (77%) required no additional treatment between 6 and 12 months, indicating sustained treatment effects. The total LS score improved significantly during this period (mean change -0.35 ± 0.60; 95% CI -0.56 to -0.14; p = 0.004), while other parameters showed non-significant improvements. In the corticosteroid group, 20 of 22 patients (91%) opted for a crossover to laser therapy. Following three laser sessions, the total LS score improved markedly (mean change -1.50 ± 0.83; 95% CI -1.89 to -1.11; p < 0.001), primarily driven by a reduction in atrophy (p < 0.001). Patient-reported improvement (PGI-I) increased from 45 to 77% (p = 0.008). At the 12-month follow-up, outcomes were comparable between the two study groups.
conclusionNon-ablative dual Nd:YAG/Er:YAG laser therapy resulted in significant and sustained clinical improvement in vulvar LS over 12 months. Crossover to laser therapy after initial corticosteroid treatment further enhanced both objective and subjective outcomes. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT03926299; date of registration: 24 April 2019.
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