The use of antibiotics in therapy resistant Lichen Sclerosus patientes

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011906-40-NL

Enrollment

Registered

2009-06-08

Start date

2009-06-22

Completion date

Unknown

Last updated

2022-08-08

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

Conditions

Vulvar Lichen Sclerosus

Interventions

Product Name: Amoxicillin Pharmaceutical Form: Capsule, hard Product Name: Benzathinebenylpenicilline Pharmaceutical Form: Powder for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Vulvar Lichen Sclerosus patients who do not or hardly respons to the standard therapy (ultrapotent corticosteroids) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of differentiated vulvar intraepithelial neoplasia or vulvar squamous cell carcinoma

Design outcomes

Primary

Measure	Time frame
Main Objective: Relief of symptoms;Secondary Objective: Improvement of clinical picture Improvement of histological abnormalities Effect on quality of life Demonstration of Borrelia species in the biopsies via culture and PCR Demonstration of antibodies to Borrelia species in serum of patients Feasibility for the patient;Primary end point(s): Relief of symptoms	—

Countries

Netherlands

Outcome results

None listed

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