Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients
Primary Purpose
Parkinson Disease, Parkinsonism, Seborrheic Dermatitis
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Botulinum toxin
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring seborrhic dermatitis, parkinson's disease, Parkinson disease parkinsonism and seborrhic dermatitis
Eligibility Criteria
Inclusion Criteria:
- Parkinson disease patients that have seborrhic dermatits
Exclusion Criteria:
- Dementia
- Renal or liver failure
- Pregnancy or breast feeding
- History of allergy to botolinum toxin
- Motor neuron disease or any other disease that insult the neuromuscular junction
- Treatment with Aminoglycoside antibiotic.
Sites / Locations
Outcomes
Primary Outcome Measures
Clinical assesment of the rash Photometric test of sebum exertion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00767546
Brief Title
Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients
Official Title
Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinsonism, Seborrheic Dermatitis
Keywords
seborrhic dermatitis, parkinson's disease, Parkinson disease parkinsonism and seborrhic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Intervention Description
60- 100 units Local injection to the rash area
Primary Outcome Measure Information:
Title
Clinical assesment of the rash Photometric test of sebum exertion
Time Frame
4 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson disease patients that have seborrhic dermatits
Exclusion Criteria:
Dementia
Renal or liver failure
Pregnancy or breast feeding
History of allergy to botolinum toxin
Motor neuron disease or any other disease that insult the neuromuscular junction
Treatment with Aminoglycoside antibiotic.
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients
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