Parkinson Disease Clinical Trial
Official title:
Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients
There's high incidence of seborrhic dermatitis among patients suffering from Parkinson's
disease. Seborrhic dermatitis is caused by increased exertion of sebaceous glands. Previous
studies have shown an increase of sebum excretion rate in parkinsonian pateints. Other
studies demonstrated improvement in seborrhic dermatitis after anticholinergic treatment.
From these studies we concluded that there might be hyperactivity of the parasympathetic
system among PD patients, that cause increased exertion of sebum, therefore local injection
of botulinium toxin, which inhibitis acetyl choline realese, might improve the rash of
seborrhic dermatitis.
40 patients suffering from Parkinson disease or other parkinsonian disorders will
participate in this study.
Before treating the patients with botulinium toxin, we will measure the sebum exertion with
the sebumeter device and make clinical evaluation of the rash. We will also take a picture
of the rash.
Then Botulinium toxin (60- 100 units) will be locally injected to the rash area.
Two weeks after the injection the patients will be called and evaluated clinicly and by the
sebumeter. Then they will be checked again after 3 weeks, after a month and after two, three
and four month's.
Exclusion criteria:
- Dementia
- Renal or liver failure
- Pregnancy or breast feeding
- History of allergy to botolinium toxin
- Motor neuron disease or any other disease that insult the neuromuscular junction
- Treatment with Amynoglycoside antibiotic. This study will include only patients that
can give informed concent.
SEBUMETER SM 810- this is the device we will use to measure sebum exertion before and after
injecting botulinium toxin. The measurement is based on grease-spot photometry. A special
tape becomes transparent in contact with the sebum on the skin surface. For the
determination of the sebum, the measuring head of the cassette is inserted into the aperture
of the device, where the transparency is measured by a light source sending light through
the tape which is reflected by a little mirror behind the tape. A photocell measures the
transparency. The light transmission represents the sebum content on the surface of the
measuring area. A microprocessor calculates the result, which is shown on the display in µg
sebum/cm² of the skin.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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