A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.

This will be a randomized, double-blind, placebo-controlled trial of two concentrations of
intralesional triamcinolone, triamcinolone 40mg/mL and triamcinolone 10mg/mL, with normal
saline as a placebo control. For subjects with lesions deemed appropriate for the study,
between one and three treatment sites will be marked with sequential lettering with a skin
marker and documented by body location. Baseline pain level of each lesion will be recorded.
At that time each lesion will be randomized in a 1:1:1 fashion to be treated with
intralesional triamcinolone 10mg/mL, triamcinolone 40mg/mL, or normal saline placebo.

Following treatment, subjects will be given a paper questionnaire that will ask them to rate
their level of pain on a 1-10 scale for each lesion, and whether they believe the target
lesion has resolved on days 1, 2, 3, 5, 7, 10, and 14. On day 14 they will also rate how
helpful they think the treatment is on a scale of 0-4. These will be patient-reported
outcomes only without any physician assessment as this is felt to be a more clinically
relevant outcome.

Aim 1. Characterize and compare the 3 regimens in terms of days to resolution of treated
lesion.

Hypotheses for Aim 1: Days to resolution of treated lesions will be fewer in the treatment
groups compared to normal saline placebo, and will be fewer with triamcinolone 40mg/mL
compared to triamcinolone 10mg/mL.

Aim 2. Characterize and compare the 3 regimens in terms of pain level on day 5.

Hypotheses for Aim 2: Rating of pain will be less in the treatment groups compared to normal
saline placebo, and will be less with triamcinolone 40mg/mL compared to triamcinolone 10mg/mL
at day 5.

Aim 3. Characterize and compare the 3 regimens in terms of patient rating of the "benefit of
the treatment Hypotheses for Aim 1: Patient rating will be more favorable the treatment
groups compared to normal saline placebo, and will be more favorable with triamcinolone
40mg/mL compared to triamcinolone 10mg/mL.

Inclusion Criteria:

1. Male and females > or = 16 years of age

2. Diagnosis or history of clinical features consistent with hidradenitis suppurativa for
>1 year

3. Patient must have an inflammatory lesion at the time of treatment. This can be an
inflammatory nodule defined by a tender, palpable subcutaneous nodule, or an abscess
defined as as fluctuant, painful, subcutaneous nodule. Lesions greater than 2
centimeters in size will not be excluded. Inflammatory nodules or abscesses can be
treated if they are associated with a sinus tract, which is a chronic HS lesion
defined by tunneled lesion with multiple openings to the surface of the skin. Sinus
tracts without associated nodules or abscesses will not be treatment targets.

4. Patient must be off of antibiotics or on a stable course of oral antibiotics for >4
weeks prior to the baseline visit. Allowable antibiotics during treatment course are
topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral
minocycline, or oral clindamycin +/- rifampin.

5. Must be able to provide adequate informed consent for themselves

Exclusion Criteria:

1. Any patient with signs of active infection at the time of screening that is not
related to their hidradenitis suppurativa

2. Patients who have been on non-permitted antibiotics in the 4 weeks prior to baseline.
Allowable antibiotics during treatment course are topical clindamycin, topical
chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/-
rifampin.

3. Patients who have had surgical intervention of the treated body region (i.e., right
axilla) beyond incision and drainage procedures in the last 8 weeks or with open
surgical wounds in the treatment region.

4. Patients who have been started on immunomodulatory or biologic treatment (i.e.,
adalimumab, infliximab) in the past 4 weeks

5. Patients on non-stable doses of opiate analgesics for the last 14 days prior to
screening

6. Patients with history of hypersensitivity reactions to triamcinolone

7. Ongoing health or physical exam concerns which the investigator feels may put the
patient at significant risk