Alopecia Areata Clinical Trial
Official title:
Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
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.
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.
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