Treatment of lichen sclerosus with non-invasive physical plasma (LS-NIPP)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038762

Enrollment

Registered

2025-12-18

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L90.0

Interventions

Group 1: Treatment of the vulva 3 times every 4-6 weeks locally using NIPP. As this is a pilot study, no control group is planned.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histologically confirmed LS or chronic inflammation and symptoms persisting for at least 3 months despite standard local therapy (cortisone)

Exclusion criteria

Exclusion criteria: Current or past malignancy, pregnancy, other interventional studies

Design outcomes

Primary

Measure	Time frame
Subjective changes in LS symptoms due to NIPP (itching, burning, thinning of the skin (atrophy), scarring, narrowing of the vaginal opening (introitus stenosis), dyspareunia (pain during sexual intercourse), quality of life, limitations at work, everyday life. The primary endpoint is the subjective change in symptoms of LS due to NIPP with the above-mentioned symptoms. The parameters are evaluated before the start of the study, at each treatment (3 times every 4-6 weeks), and at follow-up (3 months after completion of the study) using a questionnaire completed by the patient.	—

Measure

Time frame

Subjective changes in LS symptoms due to NIPP (itching, burning, thinning of the skin (atrophy), scarring, narrowing of the vaginal opening (introitus stenosis), dyspareunia (pain during sexual intercourse), quality of life, limitations at work, everyday life. The primary endpoint is the subjective change in symptoms of LS due to NIPP with the above-mentioned symptoms. The parameters are evaluated before the start of the study, at each treatment (3 times every 4-6 weeks), and at follow-up (3 months after completion of the study) using a questionnaire completed by the patient.

—

Secondary

Measure	Time frame
Objective findings (photographic documentation, scale): size of hyperkeratotic areas, size of atrophic areas, extent of introitus stenosis	—

Countries

Germany

Contacts

Public ContactCarolin Schröder

Universitätsklinik Bonn, Klinik für Gynäkologie

carolin.schroeder@ukbonn.de0228 287 15444

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026