Trial record 1 of 2 for:    Open Studies | "Hidradenitis Suppurativa"
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Henry Ford Health System
Sponsor:
Collaborator:
Microdermis Corporation
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01818167
First received: March 20, 2013
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Hidradenitis Suppurativa
Drug: 10% Benzoyl Peroxide Topical Body Wash
Drug: Provodine Topical Cream

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • 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:

    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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
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)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818167

Contacts
Contact: Virginia J Reeder, MD 313-916-6964 vreeder1@hfhs.org
Contact: Prescilia N Isedeh, MD 313-916-6964 pisedeh1@hfhs.org

Locations
United States, Michigan
Henry Ford Medical Center Department of Dermatology Recruiting
Detroit, Michigan, United States, 48202
Contact: Virginia J Reeder, MD    313-916-6964    vreeder1@hfhs.org   
Contact: Prescilia N Isedeh, MD    313-916-6964    pisedeh1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Microdermis Corporation
Investigators
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Dermatology
  More Information

No publications provided

Responsible Party: Iltefat Hamzavi, Senior Staff Physician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01818167     History of Changes
Other Study ID Numbers: Microdermis-100
Study First Received: March 20, 2013
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Hidradenitis Suppurativa
HS
Acne Inversa
Velpeau's disease
Verneuil's disease

Additional relevant MeSH terms:
Hidradenitis Suppurativa
Hidradenitis
Bacterial Infections
Infection
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Suppuration
Sweat Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014