Hidradenitis SuppurativaNCT01818167
An Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide Wash for the Treatment of Hidradenitis Suppurativa.
A study testing 10% Benzoyl Peroxide Topical Body Wash and Provodine Topical Cream in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- 10% Benzoyl Peroxide Topical Body Wash and Provodine Topical Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2013to 21 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Medical Center Department of Dermatology
Detroit, Michigan, 48202
About this study
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
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- 10% Benzoyl Peroxide Topical Body Wash, Provodine Topical Cream
- Keywords
- Hidradenitis Suppurativa, HS, Acne Inversa, Velpeau's disease, Verneuil's disease
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Benzoyl Peroxide Topical Body WashDrug
Provodine Topical CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Provodine Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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)
Measured: 4 months
Secondary outcomes (2)
Skin Irritation Index
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.
Measured: 4 months
Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study start5 Jan 2013
- Primary completion31 Dec 2014
- Study completion21 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Microdermis Corporation
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat H Hamzavi, MD, Principal investigator, Henry Ford Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818167
- Sponsor's protocol ID
- Microdermis-100
- Status last verified
- Feb 2022
- First submitted
- 20 Mar 2013
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01818167
- Acronym / sponsor ID
- Microdermis-100
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, HS, Acne Inversa, Velpeau's disease, Verneuil's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Microdermis Corporation
- Study start
- 5 Jan 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 21 Jan 2015 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10% Benzoyl Peroxide Topical Body Wash | Active comparator | Drug: 10% Benzoyl Peroxide Topical Body WashSubjects will use 10% benzoyl peroxide twice daily. The product will be applied to the affected areas, left on for 45 seconds, then rinsed off. |
| Provodine Topical Cream | Active comparator | Drug: Provodine Topical CreamSubjects will use Provodine Topical Cream twice daily. The product will be applied to the affected areas, left on for 45 seconds, then rinsed off. |
Who may qualify
- Ages
- 13 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- For inclusion, the subject must:
Key exclusion criteria (7 listed)
- Subjects who meet the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% Benzoyl Peroxide Topical Body Wash | Drug | 10% Benzoyl Peroxide Topical Body Wash |
| Provodine Topical Cream | Drug | Provodine Topical Cream |
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)
2 secondary outcomes
Skin Irritation Index
Time frame: 4 months
Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iltefat H Hamzavi, MD principal investigator
Henry Ford Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% Benzoyl Peroxide Topical Body Wash and Provodine Topical Cream in people with Hidradenitis Suppurativa, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hidradenitis Suppurativa European Research Group (HISERG) scale (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.