The use of antibiotics in therapy resistant Lichen Sclerosus patientes
Phase 1
- Conditions
- Vulvar Lichen Sclerosus
- Registration Number
- EUCTR2009-011906-40-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 10
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
History of differentiated vulvar intraepithelial neoplasia or vulvar squamous cell carcinoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Relief of symptoms;Secondary Objective: Improvement of clinical picture<br>Improvement of histological abnormalities<br>Effect on quality of life<br>Demonstration of Borrelia species in the biopsies via culture and PCR<br>Demonstration of antibodies to Borrelia species in serum of patients<br>Feasibility for the patient;Primary end point(s): Relief of symptoms
- Secondary Outcome Measures
Name Time Method