A Phase 2 interventional study of Gentian Violet in Hidradenitis Suppurativa, sponsored by Wake Forest University Health Sciences. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
Browse Hidradenitis Suppurativa studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
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.
Drug: Gentian Violet
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.
Also known as: crystal violet
Skin's Redness
Subjects rate site redness on a scale from 1 (no redness) to 5 (severe redness)
Time frame: baseline pre-treatment
Skin's Redness
Subjects rate skin redness at treatment site on a scale from 1 (no redness) to 5 (severe redness)
Time frame: 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)
Time frame: baseline pre-treatment
Skin's Drainage
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Time frame: 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)
Time frame: baseline pre-treatment
Skin's Pain
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Time frame: 1 month post-treatment
Plan to share: No
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This study is withdrawn, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences