Status:

COMPLETED

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

Lead Sponsor:

Henry Ford Health System

Collaborating Sponsors:

Microdermis Corporation

Conditions:

Hidradenitis Suppurativa

Eligibility:

All Genders

13-120 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 5 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 21 2015

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT01818167

Start Date

January 5 2013

End Date

January 21 2015

Last Update

February 16 2022

Active Locations (1)

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1

Henry Ford Medical Center Department of Dermatology

Detroit, Michigan, United States, 48202