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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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 to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nina Otberg, MD | 604-875-4747 | Nina.Otberg@vch.ca |
| Canada, British Columbia | |
| Department of Dermatology, The Skin Care Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E8 | |
| Principal Investigator: | Jerry Shapiro, MD, FRCPC | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr. Jerry Shapiro ) |
| Study ID Numbers: | H06-00278, Health Canada: Control #108512 |
| Study First Received: | December 5, 2006 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00408798 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Treatment of Alopecia areata with intracutaneous injections of Botulinum Toxin A |
|
Pathological Conditions, Anatomical Alopecia Areata Hypotrichosis Botulinum Toxins |
Skin Diseases Alopecia Botulinum Toxin Type A |
|
Pathological Conditions, Anatomical Hair Diseases Alopecia Areata Hypotrichosis Botulinum Toxins Skin Diseases |
Anti-Dyskinesia Agents Therapeutic Uses Alopecia Central Nervous System Agents Pharmacologic Actions |
