Intralesional Steroids in the Treatment of Alopecia Areata

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Brief Title

Intralesional Steroids in the Treatment of Alopecia Areata

Official Title

A Phase 4 Multicenter, Randomized, Placebo Controlled Trial of 3 Doses of Intralesional Triamcinolone (KENALOG®) In the Treatment of Mild to Moderate Patch Type Alopecia Areata

Brief Summary

      This study aims to determine the frequency of response to treatment with 3 concentrations of
      IL TAC, 2.5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of side
      effects compared to treatment with placebo (sterile saline solution). After the 1st 6 months,
      nonresponders or partial responders may be treated for 6 months with open label triamcinolone
      at the dose deemed appropriate by the investigator.

      The investigators will also perform skin biopsies of the scalp and draw blood at selected
      time points in order to examine the immunohistochemical/pathological response in scalp hair
      follicles and the systemic circulation to treatment with IL TAC for alopecia areata.
    

Detailed Description

      Alopecia areata (AA) is a major medical problem and is the most prevalent autoimmune disease
      in the US. AA represents the second most common form of hair loss and causes significant
      disfigurement and psychological distress to affected individuals. AA affects more individuals
      than most other autoimmune diseases combined, including lupus erythematosus, type 1 diabetes,
      psoriasis, multiple sclerosis and rheumatoid arthritis. In contrast to these conditions,
      research into the pathogenesis and the development of innovative therapies in AA has lagged
      behind.

      Alopecia areata is a common form of hair loss which reportedly occurs in up to 1.7% of the
      population at some time in their life. Alopecia areata is apparently triggered when the
      individual's own immune system attacks hair follicles on the scalp or body resulting in hair
      loss ranging from single patches on the scalp (patch type alopecia areata) to loss of every
      hair on the scalp and body (alopecia universalis). Currently, there are limited treatment
      options for alopecia areata and unfortunately, the treatments utilized have never been
      rigorously tested in a placebo controlled trial.

      Triamcinolone (Kenalog) is a steroid solution that has been used as a treatment for alopecia
      areata for over 50 years. It is administered via injection into the scalp and appears to have
      some efficacy for patients with mild to moderate alopecia areata. The investigators currently
      do not have objective data on the frequency of occurrence of successful regrowth, the
      duration of response or the incidence of side effects. Intralesional triamcinolone (IL TAC)
      is arguably the most commonly used treatments for AA, especially in patients with less than
      50% hair loss. Despite this, there are no adequately powered, randomized controlled clinical
      trials (RCTs) examining the efficacy, safety, and duration of effect of IL TAC. In addition,
      the dosage or strength used varies among practitioners and the efficacy and safety of
      alternate doses of IL TAC has never been examined in a well designed RCT. Quantitative
      biomarkers for AA are a crucial step toward translational research aimed at clinical trials
      in AA.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Proportion of Responders

Secondary Outcome

 Number of Adverse Events

Condition

Alopecia Areata

Intervention

Intralesional Triamcinolone 2.5 mg/ml

Study Arms / Comparison Groups

 IL TAC 2.5 mg/ml
Description:  Intralesional Triamcinolone 2.5 mg/ml (IL TAC 2.5 mg/ml):
Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20

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

11

Start Date

September 2011

Completion Date

January 2018

Primary Completion Date

January 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Patients 18 to 75 years of age

          -  Patients with a diagnosis of patch type alopecia areata

          -  Patients will have up to 50% total scalp hair loss at baseline as measured by the
             Severity of Alopecia Tool (SALT) score

          -  Duration of hair loss ranging from 3 to 12 months with no evidence of regrowth present
             at baseline in the areas to be injected

        Exclusion Criteria:

          -  Patients with a history of or existing skin diseases affecting the scalp such as
             psoriasis or seborrheic dermatitis and patients with evidence of infection or skin
             cancer in the treated areas

          -  Patients in whom the diagnosis of alopecia areata is questionable

          -  Patients in whom regrowth is present/evident at baseline in the areas to be treated

          -  Patients with active medical conditions or malignancies (except adequately treated
             basal or squamous cell carcinoma of the skin) which in the opinion of the investigator
             would increase the risks associated with study participation, including patients with
             a history of recurrent infections

          -  Women of childbearing potential who are unable or unwilling to use two forms of birth
             control for the study duration or women who are pregnant or nursing

          -  Patients known to be HIV or hepatitis B or C positive or otherwise immunocompromised

          -  Patients with evidence of adrenal cortex abnormality or previous significant adverse
             reaction to intralesional steroids

          -  Patients unwilling or unable to discontinue treatments known to affect hair regrowth
             in alopecia areata

          -  Patients who have been treated with intralesional steroids, systemic steroids,
             anthralin, squaric acid, diphenylcyclopropenone (DPCP), protopic, minoxidil or other
             medication which in the opinion of the investigator may affect hair regrowth, within
             one month of the baseline visit
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Julian Mackay-Wiggan, MD, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01898806

Organization ID

AAAI5852


Responsible Party

Sponsor

Study Sponsor

Columbia University

Collaborators

 University of Minnesota

Study Sponsor

Julian Mackay-Wiggan, MD, MS, Principal Investigator, Columbia University


Verification Date

June 2019