Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00767546
First received: October 5, 2008
Last updated: October 6, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Parkinsonism
Seborrheic Dermatitis
Drug: Botulinum toxin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Clinical assesment of the rash Photometric test of sebum exertion [ Time Frame: 4 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Botulinum toxin
    60- 100 units Local injection to the rash area
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr Joseph Zoldan, Neurology department, Rabin medical center
ClinicalTrials.gov Identifier: NCT00767546     History of Changes
Other Study ID Numbers: 004988
Study First Received: October 5, 2008
Last Updated: October 6, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
seborrhic dermatitis
parkinson's disease
Parkinson disease parkinsonism and seborrhic dermatitis

Additional relevant MeSH terms:
Parkinsonian Disorders
Parkinson Disease
Dermatitis
Dermatitis, Seborrheic
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014