Gentian Violet Treatment for Hidradenitis Suppurativa

Phase 2

Not yet recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Gentian Violet

• Registration Number: NCT04388163
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Study Start: 2025-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Patients must have active HS, be willing to undergo one application of HS, and agree to follow-up in one month.

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Exclusion Criteria

• Exclusion criteria include children, absent HS lesions at the time of clinic, and cognitive/physical impairments that would make them unable to assess quality of life factors of the survey.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gentian Violet Treatment	Gentian Violet	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.

Primary Outcome Measures

Name	Time	Method
Skin's Redness	1 month post-treatment	Subjects rate skin redness at treatment site on a scale from 1 (no redness) to 5 (severe redness)
Skin's Drainage	1 month post-treatment	Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Skin's Pain	1 month post-treatment	Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States