Alopecia Areata Clinical Trial
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
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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Phase 4 |