An Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide Wash for the Treatment of Hidradenitis Suppurativa.

Hidradenitis suppurativa (HS) is a chronic, recurrent inflammatory disease of the skin. It
typically manifests as nodules and abscesses that ultimately can progress to form deep sinus
tracts, fistulas, and scarring. It affects areas of the body with apocrine gland bearing
tissue, including the anogenital, axillary and inframammary regions. The lesions are often
very painful and can chronically drain malodorous fluid, which can leave affected
individuals uncomfortable and self-conscious, or even debilitated. The pathogenesis of this
disease process is not fully understood, and the HS can be difficult to treat. Measures such
as topical antibiotic and antiseptic washes are generally thought to be beneficial for the
treatment of early stage HS. Although there have been no controlled trials for the treatment
of HS, commonly used topical washes currently include benzoyl peroxide and chlorhexidine
gluconate.

Provodine™ topical cream was designed to actively kill microbes on the skin for up to 6
hours without resulting in the irritation often associated with repetitive use of
antimicrobial products. A blinded controlled comparison of Provodine™ versus the current
standard of benzoyl peroxide wash will not only allow for an alternative treatment for early
stage HS but also provide an additional tool in the arsenal of treatments for this disease
process.

Inclusion Criteria:

- For inclusion, the subject must:

1. Be at least 13 years old.

2. Be otherwise healthy.

3. Have a diagnosis of HS.

4. Patients must have Hurley stage I or Stage II HS

5. Be able to understand the requirements of the study, the risks involved, and be
able to sign the informed consent form.

6. Agree to follow and undergo all study-related procedures.

7. If applicable, minors must have permission of legal guardian for participation
in the study.

Exclusion Criteria:

- Subjects who meet the following criteria will be excluded:

1. Patients with HS Hurley stage III will be excluded from participation in the
study

2. Patients who are pregnant or breast feeding will not be able to take part in the
study due to the unknown effects of the topical medications.

3. Concomitant use of systemic or other topical treatments for HS not involved in
current study. For cohort I, no washout period for systemic and/or topical
medications will be required. For Cohort II, there will be a 14 day minimum
washout period for systemic and topical treatments for HS.

4. Any reason the investigator feels the patient should not participate in the
study.

5. If a patient misses ≥ 2 consecutive study visits, the patient will be excluded
from further participation in this trial.

6. History of allergy to iodine or benzoyl peroxide.