The Efficacy and Safety of Different Concentrations of Localized Injections of Steroids in the Treatment of Alopecia Areata

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Brief Title

The Efficacy and Safety of Different Concentrations of Localized Injections of Steroids in the Treatment of Alopecia Areata

Official Title

Efficacy and Safety of Different Concentrations of Intralesional Triamcinolone Acetonide in Alopecia Areata: A Prospective, Randomized, Double-blind, Placebo-controlled Study

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.
    

Detailed Description

      Alopecia areata (AA) is an autoimmune disease characterized by nonscarring hair loss with
      varying degree of severity. It most commonly involves scalp hair. It was estimated to occur
      in 0.1% to 0.2% of the general population in the united states. Patchy hair loss is the most
      common pattern seen in AA.

      There are many treatment modalities available for AA, however, none of them cure the disease.
      Given the potential for spontaneous recovery in AA, studies assessing the efficacy of a
      certain therapeutic modality must be conducted in a controlled fashion. Treatment with
      intralesional corticosteroids (ILCSs) is considered the first-line therapy in adult patients
      with less than 50% scalp involvement. Use of ILCSs in AA was first reported by Kalkoff in
      1958 using hydrocortisone. There are no published randomized controlled trials on the use of
      ILCSs in AA. Triamcinolone acetonide (TA) is the most commonly used form of ILCSs. It is
      characterized by low solubility, being slowly absorbed from the injection site, prompting
      maximal local action, limiting diffusion and spread through tissue, and not giving rise to
      systemic side effects if used in therapeutic doses. Use of intralesional (IL) TA in AA was
      first described by Orentreich et al. in 1960. IL TA is usually used in concentrations ranging
      from 2.5 to 10 mg/ml. Injections (0.1 ml per injection site) are given intradermally every 4
      to 6 weeks. Abell and Munro used IL TA in the treatment of AA of varying degree of severity
      in 84 patients. The concentration used was 5 mg/ml and injections were given three times
      every 1 to 2 weeks. Fifteen patients received injections with isotonic normal saline as a
      control. Seventy one percent of patients with limited AA have shown evidence of regrowth
      compared to only 7% of patients in the control group. They also noticed that IL TA injections
      failed in all patients with rapidly progressive disease.

      Side effects of IL TA include pain at the injection site, mild bleeding, transient atrophy
      and telangiectasia, hypopigmentation, hyperpigmentation. Infection is uncommon but caution
      over bony prominences is recommended. Adrenal suppression is rare when using lower doses. It
      has been reported in one patient who received a total dose of 22.5 mg in one session and the
      serum cortisol level normalized after 3 days. It has been shown that TA at a dose of 20 mg
      does not result in adrenal suppression. Hypersensitivity reactions to TA or the vehicle
      carboxymethylcellulose are extremely rare.

      To our knowledge, there are no prospective studies comparing the efficacy and safety of
      different concentrations of IL TA in the treatment of AA. Helfman compared the therapeutic
      effect of different concentrations of IL TA in the treatment of different dermatoses. He
      included only one patient with localized AA. He injected TA using three different
      concentrations (2.5, 5, and 10 mg) and a diluent as placebo. Injections were done in 4
      different quadrants within the same patch. He noticed that there was an equivalent degree of
      hair regrowth in the three sites injected with TA, and no regrowth in the site injected with
      the diluent.

      Study Objectives

        1. To compare the efficacy of different concentrations of IL TA in the treatment of AA.

        2. To compare the side effect profile of different concentrations of IL TA when used in the
           treatment of AA.
    


Study Type

Interventional


Primary Outcome

Hair growth

Secondary Outcome

 Side effects

Condition

Alopecia Areata

Intervention

Triamcinolone acetonide

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

5

Start Date

December 2010

Completion Date

July 2014

Primary Completion Date

July 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Age > 18 years

          -  Less than 50% scalp involvement

          -  Patients should have a patch of at least 4.5 cm in the smallest diameter

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jerry Shapiro, MD FRCPC, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01246284

Organization ID

H10-02231


Responsible Party

Sponsor

Study Sponsor

University of British Columbia


Study Sponsor

Jerry Shapiro, MD FRCPC, Principal Investigator, University of British Columbia


Verification Date

June 2015