Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients

NCT00767546 | Unknown Phase 1

• 1 other identifier: 004988
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Parkinsonism; Seborrheic Dermatitis

Keywords

seborrhic dermatitis; parkinson's disease; Parkinson disease parkinsonism and seborrhic dermatitis

Outcome Measures

Primary Outcomes (1)

• Clinical assesment of the rash Photometric test of sebum exertion

  4 month

Interventions

Botulinum toxin DRUG

60- 100 units Local injection to the rash area

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson disease patients that have seborrhic dermatits

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Dermatitis, Seborrheic

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2008
• First Posted: October 7, 2008
• Study Start: May 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 7, 2008

Record last verified: 2008-10