Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of British Columbia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00408798
First received: December 5, 2006
Last updated: September 23, 2010
Last verified: September 2010

December 5, 2006
September 23, 2010
December 2010
December 2011   (final data collection date for primary outcome measure)
To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
To evaluate hair regrowth with alopecia areata subcutaneous injections of Botulinum toxin A
Complete list of historical versions of study NCT00408798 on ClinicalTrials.gov Archive Site
Hair regrowth will be assessed after 3 months and 6 months [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Hair regrowth will be assessed after 3 months and 6 months
Not Provided
Not Provided
 
Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alopecia Areata
Drug: Intracutaneous injections of Botulinum Toxin A (Botox), 0.1 cc per injection site, which equals 10 units
See Detailed Description.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
19 Years to 65 Years
No
Contact: Nina Otberg, MD 604-875-4747 Nina.Otberg@vch.ca
Canada
 
NCT00408798
H06-00278, Health Canada: Control #108512
No
Dr. Jerry Shapiro, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Jerry Shapiro, MD, FRCPC University of British Columbia
University of British Columbia
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP