Gentian Violet Treatment for Hidradenitis Suppurativa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Gentian Violet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have active HS, be willing to undergo one application of HS, and agree to follow-up in one month. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gentian Violet Treatment<br>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<br>* 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.<br>* Other names: crystal violet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HS, Gentian Violet, nonsurgical treatment