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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00408798
First received: December 5, 2006
Last updated: March 1, 2017
Last verified: March 2017
  Purpose
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 Intervention
Alopecia Areata Drug: Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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

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

Estimated Enrollment: 20
Study Start Date: October 2007
Study Completion Date: October 30, 2009
Primary Completion Date: October 30, 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units
    See Detailed Description.
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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408798

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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00408798     History of Changes
Other Study ID Numbers: H06-00278
Health Canada: Control #108512
Study First Received: December 5, 2006
Last Updated: March 1, 2017

Keywords provided by University of British Columbia:
Treatment of Alopecia areata with intracutaneous injections of Botulinum Toxin A

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
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

ClinicalTrials.gov processed this record on July 28, 2017