Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Microdermis Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy of Provodineâ„¢ topical cream to 10% benzoyl peroxide topical body wash for the treatment of early stage hidradenitis suppurativa.
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.
Provodineâ„¢ 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 Provodineâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% Benzoyl Peroxide Topical Body Wash | Drug |
| ||
| Provodine Topical Cream |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
| Patient reported Quality of Life Scores on the Dermatology Quality of Life Index and the Skindex-20 |
Not provided
Inclusion Criteria:
For inclusion, the subject must:
Exclusion Criteria:
Subjects who meet the following criteria will be excluded:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iltefat H Hamzavi, MD | Henry Ford Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Medical Center Department of Dermatology | Detroit | Michigan | 48202 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 15, 2022 | |
| Reset | Mar 10, 2022 | |
| Release | Jun 29, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 4 months |
| Reset | Jul 20, 2023 |
| Release | Jun 26, 2025 |
| Reset | Jul 15, 2025 |
| Release | Jun 4, 2026 |
| Reset | Jun 29, 2026 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 15, 2022 | Mar 10, 2022 | |||
| Jun 29, 2023 | Jul 20, 2023 | |||
| Jun 26, 2025 | Jul 15, 2025 | |||
| Jun 4, 2026 | Jun 29, 2026 |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided