NCT01246284

Brief Summary

Alopecia areata (AA) is a disease characterized by areas of hair loss. Localized steroid injections is the standard treatment for limited disease. There are no existing studies that compare different concentrations of steroids in the treatment of AA. This study will compare the efficacy and safety of different concentrations of localized steroid injections in the treatment of AA. Six treatment sessions will be done over 6 to 9 months. The investigators will compare the following concentrations: 2,5mg/ml, 5mg/ml, 10mg/ml, and normal saline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 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

November 8, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

3.6 years

First QC Date

November 8, 2010

Last Update Submit

June 3, 2015

Conditions

Alopecia Areata

Keywords

Alopecia areataIntralesionalTriamcinolone acetonideConcentration

Outcome Measures

Primary Outcomes (1)

  • Hair growth

    4-6 weeks after each treatment session

Secondary Outcomes (1)

  • Side effects

    4-6 weeks after each treatment session

Study Arms (4)

A

ACTIVE COMPARATOR

Please note that the letter are assigned to different areas of injections within the same patient. All patients will be receiving the same treatment

Drug: Triamcinolone acetonide

B

ACTIVE COMPARATOR

Please note that the letter are assigned to different areas of injections within the same patient. All patients will be receiving the same treatment

Drug: Triamcinolone acetonide

C

ACTIVE COMPARATOR

Please note that the letter are assigned to different areas of injections within the same patient. All patients will be receiving the same treatment

Drug: Triamcinolone acetonide

D

PLACEBO COMPARATOR

Please note that the letter are assigned to different areas of injections within the same patient. All patients will be receiving the same treatment.

Other: Normal saline

Interventions

Triamcinolone acetonideDRUG

Injections will be given within a 3 cm2 area of alopecia which will be divided into 4 quadrants. Three different concentrations of triamcinolone acetonide will be used: 2.5, 5, and 10 mg/ml. Each quadrant will receive injections with either triamcinolone acetonide 2.5 mg/ml, triamcinolone acetonide 5 mg/ml, triamcinolone acetonide 10 mg/ml, or normal saline as a control. Injection of 0.1 ml will be given intradermally using a 30 gauge half inch long needle attached to a 3 ml syringe. Each quadrant will receive approximately 7 injections per treatment session so the total dose of triamcinolone acetonide will be around 13 mg. Injections will be given vertically, with the beveled side of the needle directed to the opposite side and 2 mm away from the margin of the adjacent quadrant to avoid a diffusion effect. The treatment will be repeated every 4 to 6 weeks for a total of 6 treatment sessions.

ABC
Normal salineOTHER
D

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Less than 50% scalp involvement
  • Patients should have a patch of at least 4.5 cm in the smallest diameter

You may not qualify if:

  • Current episode of alopecia areata for longer than 2 years
  • Evidence of hair regrowth at baseline
  • Patients who received treatment with a topical, intralesional, or systemic agent within the past month
  • Rapidly progressing disease
  • Hypersensitivity to Triamcinolone acetonide or vehicle
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Skin Care Center, Vancouver General Hospital, 835 West 10th Ave

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Triamcinolone AcetonideSaline Solution

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

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

November 8, 2010

First Posted

November 23, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CA(1)