The use of antibiotics in therapy resistant Lichen Sclerosus patientes

Lichen Sclerosus (LS) is a chronic disorder of the skin and is considered a
premalignant condition. The cause of LS is unknown, several causative factors
have been suggested, under which an infection with Borrelia Burgdorferi. The
treatment with the best evidence of efficacy is topical ultrapotent
corticosteroid ointment. The majority of the patients responds well to this
therapy regimen, however there is a small subgroup of patients that does not or
hardly respond. In these patients, LS leads to complaints of itch and pain,
with a great impact on the quality of life. For these patients limited options
exist to treat the LS.

To examine whether the use of systemically administered antibiotics in therapy
resistant Lichen Sclerosus leads to:
- Relief of symptoms
- Improvement of clinical picture
- Improvement of histological abnormalities
- Effect on quality of life
- Demonstration of Borrelia species in the biopsies
- Demonstration of Borrelia in serum of patients
- A feasible therapeutic option for the patient (side effects, compliance with
therapy regimen)

Ten patients with histologically proven LS, who do not or hardly respond to the
standard therapy regimen will be asked to participate in the study.
Before the prescription of Penicillin G Benzathine, two biopsies will be taken
en patients will be asked to fill in a questionaire, indicate a score for their
itch (from 0 - 10). A digital photograph is made to be able to compare with the
picture after therapy.
After two doses (4 weeks) the side effects will be evaluated, the itch score
will be asked and a digital photograph taken.
After three months: itch score, a digital photograph, a biopsy when the LS has
already significantly improved and a questionnaire.
After six months: itch score, a digital photograph, a biopsy when this was not
already done at three montns and a questionnaire. When the Penicillin G
Benzathine is effective, the patient is advised to continue the use of it.

Amoxicillin tablets 500 mg for 30 days followed by a maintenance therapy with
Pencillin G benzathine 2.4 million units intramuscular, every two weeks for the
six-twelve weeks.
.

The burden and risks for the patients are small; the burden consists of four
visitis to the outpatients clinic within 6 months, two biopsies and one
venapunction. During the study 6 doses of Penicillin G Benzathine are
presribed, to be administrated intramuscular.
The risks of the procedures are bleeding and infection after the biopsies. An
allergic reaction to Penicillin or side effects. The change of an allergic
reaction is small, side effects are more common but usually are mild.