Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408798
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2006-12-05
Brief Title:
Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 01 cc or saline 09 with a total of 01 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
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 01 cc or saline 09 with a total of 01 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Health Canada Control 108512 | None | None | None |