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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
Rabin Medical Center
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 5, 2008
    Last Updated
    October 6, 2008
    Sponsor
    Rabin Medical Center
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    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

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    Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients

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