Noninvasive physical plasma in vulvar lichen sclerosus: a prospective pilot study

Background: Lichen sclerosus (LS) is a chronic inflammatory dermatosis predominantly affecting the anogenital region and is associated with significant impairment of quality of life. High-potency topical corticosteroids are the standard of care; however, some patients show inadequate response or experience relapse. Noninvasive physical plasma (NIPP) is an emerging therapeutic modality with antimicrobial and anti-inflammatory properties, but its role in LS remains unclear. Objective: To evaluate the safety, tolerability, and preliminary efficacy of NIPP as an adjunctive treatment in patients with vulvar LS refractory to topical corticosteroids. Methods: This prospective single-arm pilot study included 5 women with histologically confirmed LS and/or chronic vulvar inflammation with persistent symptoms despite topical corticosteroid therapy. Patients received at least 3 NIPP sessions (plasma care, terraplasma medical GmbH), each applied for 1 minute over a 4 × 4 cm area at intervals of 4 to 6 weeks, while continuing standard topical treatment. Clinical assessment, photographic documentation, and patient-reported outcomes using a study-specific questionnaire were collected at baseline, at each session, and at follow-up 4 to 6 weeks after the final treatment. Results: The median age was 46 years, and the median disease duration was 3 years. No consistent improvement in symptoms or clinical findings was observed following NIPP treatment. Three patients indicated willingness to undergo NIPP again, and 1 patient reported improvement in sexual well-being. No severe adverse events occurred. Treatment was generally well tolerated; however, 1 patient discontinued participation due to treatment-related discomfort. Limitations: The main limitations are small sample size, lack of a control group, and heterogeneity in disease duration and prior/current treatments. Conclusion: In this pilot study, adjunctive NIPP did not demonstrate consistent clinical benefit in vulvar LS but appeared safe and well-tolerated. Larger controlled studies are required to further assess its therapeutic potential.