Intralesional Steroids in the Treatment of 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.

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