Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients

October 6, 2008 updated by: Rabin Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical assesment of the rash Photometric test of sebum exertion
Time Frame: 4 month
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

October 5, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2008

Last Update Submitted That Met QC Criteria

October 6, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004988

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Botulinum toxin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe