Gentian Violet Treatment for Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gentian Violet
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring HS, Gentian Violet, nonsurgical treatment
Eligibility Criteria
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.
Sites / Locations
- Wake Forest School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gentian Violet Treatment
Arm 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.
Outcomes
Primary Outcome Measures
Skin's Redness
Subjects rate site redness on a scale from 1 (no redness) to 5 (severe redness)
Skin's Redness
Subjects rate skin redness at treatment site on a scale from 1 (no redness) to 5 (severe redness)
Skin's Drainage
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Skin's Drainage
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Skin's Pain
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Skin's Pain
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Secondary Outcome Measures
Full Information
NCT ID
NCT04388163
First Posted
May 11, 2020
Last Updated
August 28, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04388163
Brief Title
Gentian Violet Treatment for Hidradenitis Suppurativa
Official Title
Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
HS, Gentian Violet, nonsurgical treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gentian Violet Treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Gentian Violet
Other Intervention Name(s)
crystal violet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skin's Redness
Description
Subjects rate site redness on a scale from 1 (no redness) to 5 (severe redness)
Time Frame
baseline pre-treatment
Title
Skin's Redness
Description
Subjects rate skin redness at treatment site on a scale from 1 (no redness) to 5 (severe redness)
Time Frame
1 month post-treatment
Title
Skin's Drainage
Description
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Time Frame
baseline pre-treatment
Title
Skin's Drainage
Description
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Time Frame
1 month post-treatment
Title
Skin's Pain
Description
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Time Frame
baseline pre-treatment
Title
Skin's Pain
Description
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Time Frame
1 month post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Pichardo-Geisinger, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Pichardo, MD
Phone
336-716-1361
Email
rpichard@wakehealth.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gentian Violet Treatment for Hidradenitis Suppurativa
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