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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00408798
Recruitment Status : Completed
First Posted : December 7, 2006
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
Study Start Date : October 2007
Actual Primary Completion Date : October 30, 2009
Actual Study Completion Date : October 30, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Intervention Details:
  • Drug: Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units
    See Detailed Description.

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

Secondary Outcome Measures :
  1. Hair regrowth will be assessed after 3 months and 6 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00408798

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Canada, British Columbia
Department of Dermatology, The Skin Care Centre
Vancouver, British Columbia, Canada, V5Z 4E8
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Jerry Shapiro, MD, FRCPC University of British Columbia

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Responsible Party: University of British Columbia Identifier: NCT00408798     History of Changes
Other Study ID Numbers: H06-00278
Health Canada: Control #108512
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Keywords provided by University of British Columbia:
Treatment of Alopecia areata with intracutaneous injections of Botulinum Toxin A
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents