NCT00408798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2009

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

December 5, 2006

Last Update Submit

March 1, 2017

Conditions

Alopecia Areata

Keywords

Treatment of Alopecia areata with intracutaneous injections of Botulinum Toxin A

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Hair regrowth will be assessed after 3 months and 6 months

Interventions

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

See Detailed Description.

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with long standing alopecia areata, patches must be at least 4 cm in diameter

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, The Skin Care Centre

Vancouver, British Columbia, V5Z 4E8, Canada

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Jerry Shapiro, MD, FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2006

First Posted

December 7, 2006

Study Start

October 1, 2007

Primary Completion

October 30, 2009

Study Completion

October 30, 2009

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

CA(1)