Clinical Trial: Intralesional Steroids in the Treatment of Alopecia Areata

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Are

Brief Summary:

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. 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. 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.

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 treatm

Detailed Summary:

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.

The investigators 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.


Sponsor: Columbia University

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: July 10, 2013
Date Started: September 2011
Date Completion: June 2017
Last Updated: October 27, 2016
Last Verified: October 2016