Study Stopped
Drug company did not approve use of the drug, IRB never approved
Gentian Violet Treatment for Hidradenitis Suppurativa
Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
September 4, 2025
August 1, 2025
1.3 years
May 11, 2020
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (1)
Gentian Violet Treatment
EXPERIMENTALA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients must have active HS, be willing to undergo one application of HS, and agree to follow-up in one month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Pichardo-Geisinger, MD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2020
First Posted
May 14, 2020
Study Start
August 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share