Gentian Violet Treatment for Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04388163
• Other study ID #: IRB00063737
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Irma M Richardson, MHA
• Phone: 336-716-2903
• Email: irichard[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin's Redness	Subjects rate site redness on a scale from 1 (no redness) to 5 (severe redness)	baseline pre-treatment
Primary	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
Primary	Skin's Drainage	Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)	baseline pre-treatment
Primary	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
Primary	Skin's Pain	Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)	baseline pre-treatment
Primary	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