Back to resultsAn Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide Wash for the Treatment of Hidradenitis Suppurativa.
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
10% Benzoyl Peroxide Topical Body Wash
Provodine Topical Cream
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, HS, Acne Inversa, Velpeau's disease, Verneuil's disease
Eligibility Criteria
Inclusion Criteria:
For inclusion, the subject must:
- Be at least 13 years old.
- Be otherwise healthy.
- Have a diagnosis of HS.
- Patients must have Hurley stage I or Stage II HS
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form.
- Agree to follow and undergo all study-related procedures.
- 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:
- Patients with HS Hurley stage III will be excluded from participation in the study
- 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.
- 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.
- Any reason the investigator feels the patient should not participate in the study.
- If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial.
- History of allergy to iodine or benzoyl peroxide.
Sites / Locations
- Henry Ford Medical Center Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
10% Benzoyl Peroxide Topical Body Wash
Provodine Topical Cream
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20
Full Information
NCT ID
NCT01818167
First Posted
March 20, 2013
Last Updated
February 15, 2022
Sponsor
Henry Ford Health System
Collaborators
Microdermis Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01818167
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2013 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
January 21, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Microdermis Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa, HS, Acne Inversa, Velpeau's disease, Verneuil's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10% Benzoyl Peroxide Topical Body Wash
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Provodine Topical Cream
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
10% Benzoyl Peroxide Topical Body Wash
Intervention Type
Drug
Intervention Name(s)
Provodine Topical Cream
Primary Outcome Measure Information:
Title
Hidradenitis Suppurativa European Research Group (HISERG) scale
Description
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)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Skin Irritation Index
Description
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.
Time Frame
4 months
Title
Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For inclusion, the subject must:
Be at least 13 years old.
Be otherwise healthy.
Have a diagnosis of HS.
Patients must have Hurley stage I or Stage II HS
Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form.
Agree to follow and undergo all study-related procedures.
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:
Patients with HS Hurley stage III will be excluded from participation in the study
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.
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.
Any reason the investigator feels the patient should not participate in the study.
If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial.
History of allergy to iodine or benzoyl peroxide.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat H Hamzavi, MD
Organizational Affiliation
Henry Ford Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Medical Center Department of Dermatology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide Wash for the Treatment of Hidradenitis Suppurativa.
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