Clinical trial NCT01818167: An Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide Wash for the Treatment of Hidradenitis Suppurativa.
Official title: A Prospective Multi-Center Blinded, Randomized, Controlled Clinical Trial Comparing the Efficacy of Provodine Topical Body Wash Versus 10% Benzoyl Peroxide Topical Body Wash for the Treatment of Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
HS
Acne Inversa
Velpeau's disease
Verneuil's disease
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Microdermis Corporation
First posted: 2013-03-26
Enrollment: 25
Sex: ALL
Minimum age (years): 13
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of Provodine™ topical cream to 10% benzoyl peroxide topical body wash for the treatment of early stage hidradenitis suppurativa.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hidradenitis Suppurativa European Research Group (HISERG) scale
timeFrame: 4 months
Secondary outcomes:
measure: Skin Irritation Index
timeFrame: 4 months
measure: Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20
timeFrame: 4 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Medical Center Department of Dermatology
state: Michigan
Study officials:
affiliation: Henry Ford Dermatology
name: Iltefat H Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References: