Not provided
Not provided
Not provided
Not provided
Not provided
Drug company did not approve use of the drug, IRB never approved
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a survey study being conducted to describe how subjects with Hidradenitis suppurativa (HS) respond to treatment with gentian violet. The study will rely primarily on qualitative survey responses and quantitative changes in skin appearance.
Hidradenitis suppurativa (HS) is a chronic disease of the folliculopilosebaceous unit, often found in intertriginous areas of the body. The pain and impairment of HS leads patients to report a decreased quality of life, even in comparison to other debilitating cutaneous disease states. Pharmalogic management of HS can vary from topical antibiotics or intralesional corticosteroids for mild cases to immunosuppressants and biologic agents in refractory cases. Gentian violet is a topical antiseptic used to treat many cutaneous yeast infections. It also has a role in improving wound healing in sites of active ulceration. It is our hypothesis that gentian violet will help minimize skin trauma in sites of active HS to promote improved wound healing and quality of life.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gentian Violet Treatment | Experimental | A single application of gentian violet will be topically applied to the site(s) of active HS involvement by a trained staff member. The sites will then be bandaged by staff and patients will be instructed about home maintenance procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentian Violet | Drug | Gentian violet is a topical antiseptic used to treat many cutaneous yeast infections. It also has a role in improving wound healing in sites of active ulceration. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin's Redness | Subjects rate site redness on a scale from 1 (no redness) to 5 (severe redness) | baseline pre-treatment |
| Skin's Redness | Subjects rate skin redness at treatment site on a scale from 1 (no redness) to 5 (severe redness) | 1 month post-treatment |
| Skin's Drainage | Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage) | baseline pre-treatment |
| Skin's Drainage | Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage) | 1 month post-treatment |
| Skin's Pain | Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain) | baseline pre-treatment |
| Skin's Pain | Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain) | 1 month post-treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rita Pichardo-Geisinger, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D005840 | Gentian Violet |
| ID | Term |
|---|---|
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |