Gentian Violet Treatment for Hidradenitis Suppurativa

Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Gentian Violet

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Irma M Richardson, MHA; Phone Number: 336-716-2903; Email: irichard@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine
      • Contact: Rita Pichardo, MD; Phone Number: 336-716-1361; Email: rpichard@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gentian Violet Treatment; 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.; Other Names: crystal violet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Rita Pichardo-Geisinger, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: HS; Gentian Violet; nonsurgical treatment
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Anti-Infective Agents, Local; Anti-Infective Agents; Gentian Violet
• Other Study ID Numbers: IRB00063737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No