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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin

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 Summary:

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 inje
Sponsor: University of British Columbia

Current Primary Outcome: To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A [ Time Frame: Unspecified ]

Original Primary Outcome: To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A

Current Secondary Outcome: Hair regrowth will be assessed after 3 months and 6 months [ Time Frame: Unspecified ]

Original Secondary Outcome: Hair regrowth will be assessed after 3 months and 6 months

Information By: University of British Columbia

Dates:
Date Received: December 5, 2006
Date Started: October 2007
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017