An Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide 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.
Drug: 10% Benzoyl Peroxide Topical Body Wash
Drug: Provodine Topical Cream
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|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|
- Hidradenitis Suppurativa European Research Group (HISERG) scale [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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)
- Skin Irritation Index [ Time Frame: 4 months ] [ Designated as safety issue: No ]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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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|
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.
|Contact: Virginia J Reeder, MDemail@example.com|
|Contact: Prescilia N Isedeh, MDfirstname.lastname@example.org|
|United States, Michigan|
|Henry Ford Medical Center Department of Dermatology||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Virginia J Reeder, MD 313-916-6964 email@example.com|
|Contact: Prescilia N Isedeh, MD 313-916-6964 firstname.lastname@example.org|
|Principal Investigator:||Iltefat H Hamzavi, MD||Henry Ford Dermatology|