Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
Verified by University of British Columbia December 2006
| Sponsored by: |
University of British Columbia |
| Information provided by: |
University of British Columbia |
| ClinicalTrials.gov Identifier: |
NCT00408798 |
|
Purpose
The purpose of this study is to examine prospectively the safety and efficacy of Botulinum Toxin A (Botox) injections in the treatment of patients with alopecia areata of the scalp.
| Condition |
Intervention |
Alopecia Areata
|
Drug: Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units
|
MedlinePlus related topics: Hair Diseases and Hair Loss
Genetics Home Reference related topics: Hair Diseases and Hair Loss
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
Further study details as provided by University of British Columbia:
Primary Outcomes: To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A
Secondary Outcomes: Hair regrowth will be assessed after 3 months and 6 months
Expected Total Enrollment: 20
Study start: January 2007
Hypothesis Intralesional injections of Botulinum Toxin A can be used as a treatment for AA. Potential points of action of this treatment include changes in neurotransmitters, which either directly or via neuroimmunologic mechanisms influence cytocines that are responsible for the hair growth arrest in alopecia areata.
Justification Botulinum Toxin A is an antagonist of Acetylcholine esterase and is used to treat facial wrinkles and hyperhidrosis. One ampoule contains Clostridium Botulinum Toxin Typ A (900kD) 100 E, other components are human albumin and sodium choride. The investigator has learnt about the potential effect of this treatment in AA from personal communication.
Objectives Over a period of 6 month, to assess the therapeutic efficacy and safety of a regimen of two interlesional injections of Botulinum Toxin A at 0 and 3 months, in patients with alopecia areata of the scalp, compared to placebo.
Research Method A total of 20 eligible patients will be enrolled in the study. All patients will receive treatment into one half of their target area and placebo treatment into the other half of their target area.
Measurement of the severity of scalp alopecia areata will be based on the extent terminal scalp hair loss. The Severity of Alopecia Tool (SALT) will be used, which determines the percent of scalp involvement with disease as calculated according to specifications detailed in the Alopecia Areata Investigational Guidelines by Olsen et al..
A circular target area of at least 4 cm diameter will be chosen on the scalp.
At visit 0 and after 3 months at visit 1, the two right quandrants of the target area will each be injected with either Botulinum Toxin A (Botox„¥) at a dose of 10 Units (0.1 cc) or saline 0.9% with a total of 0.1 cc.
The left two quadrants will be injected with the other medication. The patient will not know which half of the target area is injected with the drug or placebo.
The chosen side will be noted in the patient documentation by one investigator. The second investigator who does the efficacy assessment with the qualitative scale will not know which side is treated with Botulinum Toxin A or placebo.
At every visit, extent of the hair loss in the test area will be examined, based on a semi quantitative assessment scale ranging from 0 to 100. The investigator does not know which side had been treated.
There had been unpublished anecdotal reports of the use and the efficacy of Botulinumtoxin A in patients with alopecia areata. No further evidence is available so fare.
Eligibility
Ages Eligible for Study: 19 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patients with long standing alopecia areata, patches must be at least 4 cm in diameter
Exclusion Criteria:
- Intake of drugs that interfere with Botulinum toxin A such as gentamicin, tobramycin, clindamycin and lincomycin; medications used to treat heart rhythm problems, such as quinidine; and medications used to treat other conditions, such as myasthenia gravis, ALS or Alzheimer's disease.
- Neuromuscular disorders such as Myasthenia gravis and Lambert-Eaton-Syndrome.
- Treatment with another investigational drug within 4 weeks prior to anticipated first treatment.
- Females who are pregnant, planning to become pregnant during the study period, or breastfeeding.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00408798
Canada, British Columbia
Department of Dermatology, The Skin Care Centre, Vancouver, British Columbia, V5Z 4E8, Canada
Nina Otberg, MD 604-875-4747
nina.otberg@vch.ca
Jerry Shapiro, MD, FRCPC, Principal Investigator
Study chairs or principal investigators
Jerry Shapiro, MD, FRCPC, Principal Investigator, University of British Columbia
More Information
Study ID Numbers: H06-00278; Health Canada: Control #108512
Last Updated: December 6, 2006
Record first received: December 5, 2006
ClinicalTrials.gov Identifier:
NCT00408798
Health Authority: Canada: Health Canada
