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.