Intralesional Steroids in the Treatment of Alopecia Areata

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Columbia University
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Julian M. Mackay-Wiggan, Columbia University
ClinicalTrials.gov Identifier:
NCT01898806
First received: July 10, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 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. We currently do not have objective data on the frequency of occurrence of successful regrowth, the duration of response or the incidence of side effects. In addition, there is disagreement between clinicians regarding the dose of intralesional triamcinolone (IL TAC) that is considered most effective.

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 non or partial responders may be treated for 6 months with open label triamcinolone at the dose deemed appropriate by the investigator.

We 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.


Condition Intervention Phase
Alopecia Areata
Drug: Triamcinolone 2.5 mg/ml
Drug: Triamcinolone 5 mg/ml
Drug: Triamcinolone 10 mg/ml
Drug: Intralesional Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • SALT Score [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence and severity of adverse effects (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.


Estimated Enrollment: 68
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IL TAC 2.5 mg/ml
Intralesional Triamcinolone at a strength of 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
Drug: 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
Experimental: IL TAC 5 mg/ml
Intralesional Triamcinolone at a strength of 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.
Drug: 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
Experimental: IL TAC 10 mg/ml
Intralesional Triamcinolone at a strength of 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.
Drug: 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
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.
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

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. Intralesional steroids (IL TAC) are 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.

We will evaluate the efficacy of treating patients with moderate AA for 6mths with IL TAC at a strength of 2.5mg/ml, 5mg/ml, IL TAC 10mg/ml versus intralesional saline (placebo) followed by a 6mth follow-up period to evaluate relapse and to identify a clinical correlation between treatment outcome and down modulation of key AA-associated immunohistopathological markers and biomarkers in the treated skin; including NKG2DL expression in the hair follicle, immune infiltration (CD8+NKG2D+ cells) and expression of interferon response genes. After the 1st 6 months non or partial responders may be treated with open label triamcinolone at the dose deemed appropriate by the investigator.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) (2) 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, DPCP (diphenylcycloprophenone), protopic, minoxidil or other medication which in the opinion of the investigator may affect hair regrowth, within one month of the baseline visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898806

Contacts
Contact: Julian Mackay-Wiggan, MD, MS 212-305-6953 jc299@columbia.edu
Contact: Grace Ulerio 212-305-6953 gu2102@columbia.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Maria Hordinsky, MD    612-625-8625    hordi001@umn.edu   
Principal Investigator: Maria Hordinsky, MD         
United States, New York
Columbia University Medical Center, Department of Dermatology Recruiting
New York, New York, United States, 10032
Contact: Julian Mackay-Wiggan, MD, MS    212-305-6953    jc299@columbia.edu   
Contact: Grace Ulerio    212-305-6953    gu2102@columbia.edu   
Principal Investigator: Julian Mackay-Wiggan, MD, MS         
Sponsors and Collaborators
Columbia University
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Julian Mackay-Wiggan, MD, MS Columbia University
  More Information

No publications provided

Responsible Party: Julian M. Mackay-Wiggan, Principal Investigator, Columbia University
ClinicalTrials.gov Identifier: NCT01898806     History of Changes
Other Study ID Numbers: AAAI5852
Study First Received: July 10, 2013
Last Updated: July 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Alopecia Areata
Kenalog
Triamcinolone

Additional relevant MeSH terms:
Hair Diseases
Alopecia
Alopecia Areata
Hypotrichosis
Skin Diseases
Pathological Conditions, Anatomical
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014