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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Henry Ford Health System

Current Primary Outcome: Hidradenitis Suppurativa European Research Group (HISERG) scale [ Time Frame: 4 months ]

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:

  1. Anatomical region involved (axilla, groin, gluteal or other region or inframammary region left and/or right: 3 points per region involved).
  2. Number and scores of lesions (abscesses, nodules, fistulas, scars: points per lesion of all regions involved: nodules 2, fistulas 4, scars 1, others 1)
  3. 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)
  4. Are all lesions clearly separated by normal skin? In each region (yes 0/no 6)
  5. Extent of erythema, edema, pain and purulent discharge of each anatomic site (0-3 for each clinical indicator)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Skin Irritation Index [ Time Frame: 4 months ]
    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 ]


Original Secondary Outcome: Same as current

Information By: Henry Ford Health System

Dates:
Date Received: March 20, 2013
Date Started: March 2013
Date Completion: December 2013
Last Updated: March 21, 2013
Last Verified: March 2013