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Intralesional Steroids in the Treatment of Alopecia Areata

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ClinicalTrials.gov Identifier: NCT01898806
Recruitment Status : Terminated (The PI left the Columbia University Medical Center. Study was not Completed.)
First Posted : July 12, 2013
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date  ICMJE July 10, 2013
First Posted Date  ICMJE July 12, 2013
Results First Submitted Date  ICMJE March 22, 2019
Results First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
Proportion of Responders [ Time Frame: Up to 48 weeks ]
Comparison of the proportion of responders in each group, with response defined as 50% change (% change NOT absolute change) in SALT score from baseline (50% regrowth at week 24).
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
SALT Score [ Time Frame: Up to 12 months ]
Comparison of the proportion of responders in each group, with response defined as 50% change (% change NOT absolute change) in SALT score from baseline (50% regrowth at week 24).
Change History Complete list of historical versions of study NCT01898806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
Number of Adverse Events [ Time Frame: 48 weeks ]
Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
Number of Adverse Events [ Time Frame: 12 months ]
Incidence and severity of adverse effects (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intralesional Steroids in the Treatment of Alopecia Areata
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: Intralesional Triamcinolone 2.5 mg/ml
    Intralesional Triamcinolone at a strength of 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.
    Other Names:
    • Kenalog
    • IL TAC 2.5 mg/ml
  • Drug: Intralesional Triamcinolone 5 mg/ml
    Intralesional Triamcinolone at a strength of 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.
    Other Names:
    • Kenalog
    • IL TAC 5 mg/ml
  • Drug: Intralesional Triamcinolone 10 mg/ml
    Intralesional Triamcinolone at a strength of 10 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.
    Other Names:
    • Kenalog
    • IL TAC 10 mg/ml
  • Drug: Intralesional Saline
    Intralesional Saline (Placebo). Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss for a total of 6 months.
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: IL TAC 2.5 mg/ml

    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

    Intervention: Drug: Intralesional Triamcinolone 2.5 mg/ml
  • Experimental: IL TAC 5 mg/ml

    Intralesional Triamcinolone 5mg/ml (IL TAC 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.

    Intervention: Drug: Intralesional Triamcinolone 5 mg/ml
  • Experimental: IL TAC 10 mg/ml

    Intralesional Triamcinolone 10mg/ml (IL TAC 10 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.

    Intervention: Drug: Intralesional Triamcinolone 10 mg/ml
  • Placebo Comparator: Placebo

    Intralesional Saline (Placebo):

    Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20. Open label treatment with IL kenalog at the dose deemed most appropriate may be administered after the 1st 6 months in nonresponders or partial responders.

    Intervention: Drug: Intralesional Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2013)
68
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01898806
Other Study ID Numbers  ICMJE AAAI5852
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE University of Minnesota - Clinical and Translational Science Institute
Investigators  ICMJE
Principal Investigator: Julian Mackay-Wiggan, MD, MS Columbia University
PRS Account Columbia University
Verification Date June 2019

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