Gentian Violet Treatment for Hidradenitis Suppurativa

Wake Forest University (WFU)

Status and phase: Not yet enrolling; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Gentian Violet

Study type: Interventional

Funder types: Other

Identifiers

NCT04388163

IRB00063737

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Gentian Violet Treatment

Experimental group

Description:

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.

Treatment:

Drug: Gentian Violet