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

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

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: 10% Benzoyl Peroxide Topical Body Wash; Drug: Provodine Topical Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 116 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10% Benzoyl Peroxide Topical Body Wash; Subjects will use 10% benzoyl peroxide twice daily. The product will be applied to the affected areas, left on for 45 seconds, then rinsed off.	Drug: 10% Benzoyl Peroxide Topical Body Wash
Active Comparator: Provodine Topical Cream; Subjects will use Provodine Topical Cream twice daily. The product will be applied to the affected areas, left on for 45 seconds, then rinsed off.	Drug: Provodine Topical Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hidradenitis Suppurativa European Research Group (HISERG) scale	Assessment of the degree of involvement of HS will be performed at each study visit using the Hidradenitis Suppurativa European Research Group (HISERG) scale outlined below: Anatomical region involved (axilla, groin, gluteal or other region or inframammary region left and/or right: 3 points per region involved).; Number and scores of lesions (abscesses, nodules, fistulas, scars: points per lesion of all regions involved: nodules 2, fistulas 4, scars 1, others 1); The longest distance between two relevant lesions, i.e., nodules and fistulas, in each region, or size if only one lesion (<5cm 2, <10cm 4, >10cm 8); Are all lesions clearly separated by normal skin? In each region (yes 0/no 6); Extent of erythema, edema, pain and purulent discharge of each anatomic site (0-3 for each clinical indicator)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Irritation Index	Subjects will be evaluated weekly for any signs or symptoms of local skin irritation by a study physician using the following Skin Irritation Index scoring system, which includes ratings for erythema, edema, scaling and dryness, rash and discomfort.	4 months
Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20		4 months

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Microdermis Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2013
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): January 21, 2015

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 26, 2013

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: HS; Hidradenitis Suppurativa; Acne Inversa; Velpeau's disease; Verneuil's disease
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Dermatologic Agents; Benzoyl Peroxide
• Other Study ID Numbers: Microdermis-100