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Gentian Violet for Hidradenitis Suppurativa
Phase 2
Waitlist Available
Led By Rita Pichardo-Geisinger, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have active HS, be willing to undergo one application of HS, and agree to follow-up in one month.
Be between 18 and 65 years old
Must not have
Cognitive/physical impairments that would make them unable to assess quality of life factors of the survey.
Absent HS lesions at the time of clinic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how well gentian violet works to treat HS by surveying patients and measuring changes in skin appearance.
Who is the study for?
This trial is for adults with active Hidradenitis Suppurativa (HS), a skin condition. Participants must be willing to have one treatment of Gentian Violet and agree to a follow-up after one month. It's not suitable for children, those without current HS lesions, or individuals unable to evaluate their quality of life for the survey.
What is being tested?
The study tests how effective Gentian Violet is in treating HS by examining changes in the skin and collecting patient feedback through surveys about their experience and results after treatment.
What are the potential side effects?
While specific side effects are not listed, Gentian Violet may cause skin irritation, staining of the skin and nearby objects, possible allergic reactions, or other localized effects at the site of application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have active HS and agree to one treatment and a follow-up in a month.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can understand and respond to questions about my quality of life.
Select...
I do not have any active skin lesions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Skin's Drainage
Skin's Pain
Skin's Redness
Side effects data
From 2014 Phase 3 trial • 221 Patients • NCT0142773853%
Blood albumin decreased
47%
Blood sodium decreased
39%
Blood calcium decreased
30%
Haemoglobin decreased
28%
Aspartate aminotransferase increased
28%
Oral candidiasis
20%
Neutrophil count decreased
19%
Blood bicarbonate decreased
16%
Blood alkaline phosphatase increased
15%
White blood cell count decreased
11%
Alanine aminotransferase increased
10%
Oral disorder
10%
Blood magnesium decreased
9%
Blood uric acid increased
9%
Blood phosphorus decreased
8%
Blood potassium decreased
8%
Cough
8%
Pulmonary tuberculosis
8%
Cheilitis
7%
Chest pain
6%
Stomatitis
6%
Blood creatinine increased
6%
Blood glucose increased
6%
Oropharyngeal plaque
5%
Diarrhoea
5%
Leukoplakia oral
5%
Odynophagia
5%
Oral mucosal erythema
5%
Oral hairy leukoplakia
5%
Pneumonia bacterial
5%
Pyrexia
2%
Death
2%
Gastroenteritis
2%
Anaemia
2%
Pneumonia
1%
Oesophageal candidiasis
1%
Renal failure acute
1%
HIV infection WHO clinical stage IV
1%
Haemoptysis
1%
Blood glucose decreased
1%
Encephalitis viral
1%
Meningitis cryptococcal
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gentian Violet
Nystatin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gentian Violet TreatmentExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Gentian Violet
2011
Completed Phase 3
~230
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,477,919 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
72 Patients Enrolled for Hidradenitis Suppurativa
Rita Pichardo-Geisinger, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a child.I can understand and respond to questions about my quality of life.I have active HS and agree to one treatment and a follow-up in a month.I do not have any active skin lesions.
Research Study Groups:
This trial has the following groups:- Group 1: Gentian Violet Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Hidradenitis Suppurativa Patient Testimony for trial: Trial Name: NCT04388163 — Phase 2