NCT01818167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2015

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

March 20, 2013

Last Update Submit

February 15, 2022

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis SuppurativaHSAcne InversaVelpeau's diseaseVerneuil's disease

Outcome Measures

Primary Outcomes (1)

  • 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: 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)

    4 months

Secondary Outcomes (2)

  • Skin Irritation Index

    4 months

  • Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20

    4 months

Study Arms (2)

10% Benzoyl Peroxide Topical Body Wash

ACTIVE COMPARATOR

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

Provodine Topical Cream

ACTIVE COMPARATOR

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

Interventions

10% Benzoyl Peroxide Topical Body WashDRUG
10% Benzoyl Peroxide Topical Body Wash
Provodine Topical CreamDRUG
Provodine Topical Cream

Eligibility Criteria

Age13 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Medical Center Department of Dermatology

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Officials

  • Iltefat H Hamzavi, MD

    Henry Ford Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Physician

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 26, 2013

Study Start

January 5, 2013

Primary Completion

December 31, 2014

Study Completion

January 21, 2015

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

US(1)