Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin

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Brief Title

Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin

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 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 (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.
    


Study Type

Interventional


Primary Outcome

To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A

Secondary Outcome

 Hair regrowth will be assessed after 3 months and 6 months

Condition

Alopecia Areata

Intervention

Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

October 2007

Completion Date

October 30, 2009

Primary Completion Date

October 30, 2009

Eligibility 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.
      

Gender

All

Ages

19 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jerry Shapiro, MD, FRCPC, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00408798

Organization ID

H06-00278

Secondary IDs

Health Canada: Control #108512

Responsible Party

Sponsor

Study Sponsor

University of British Columbia


Study Sponsor

Jerry Shapiro, MD, FRCPC, Principal Investigator, University of British Columbia


Verification Date

March 2017