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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post-treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I have active HS and agree to one treatment and a follow-up in a month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Skin's Drainage
Skin's Pain
Skin's Redness

Side effects data

From 2014 Phase 3 trial • 221 Patients • NCT01427738
53%
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

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
1,239 Previous Clinical Trials
1,004,167 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

Gentian Violet (Dye) Clinical Trial Eligibility Overview. Trial Name: NCT04388163 — Phase 2
Hidradenitis Suppurativa Research Study Groups: Gentian Violet Treatment
Hidradenitis Suppurativa Clinical Trial 2023: Gentian Violet Highlights & Side Effects. Trial Name: NCT04388163 — Phase 2
Gentian Violet (Dye) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04388163 — Phase 2
Hidradenitis Suppurativa Patient Testimony for trial: Trial Name: NCT04388163 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical experiment currently available to participants?

"As documented in clinicaltrials.gov, this medical study has ceased pursuing participants since September 26th 2022 and is no longer actively recruiting. Nevertheless, there are a further 39 trials that patients can enrol in at the current moment."

Answered by AI

For what types of conditions is Gentian Violet typically employed?

"Gentian Violet is routinely prescribed as a remedy for many infections such as bacterial, fungal, and communicable diseases."

Answered by AI

What other forays into research have there been regarding Gentian Violet?

"Currently, two trials are assessing the efficacy of Gentian Violet. However, neither is in Phase 3 yet; both studies take place in Winston-Salem within North carolina."

Answered by AI

How many individuals have enrolled in this clinical trial?

"This medical trial is currently not recruiting. It was first posted on December 1st 2022 and last updated September 26th 2022. If you are searching for other opportunities, there are 37 studies actively looking for hidradenitis suppurativa participants and 2 clinical trials seeking individuals with Gentian Violet treatment needs."

Answered by AI

Has Gentian Violet been certified by the FDA?

"Our team gauged Gentian Violet's safety at a 2 on our 1 to 3 scale due to the Phase 2 trial, which demonstrates some evidence of security but not necessarily efficacy."

Answered by AI

Does this experimentation involve participants aged 25 or older?

"As detailed in the trial's eligibility requirements, participants must be over 18 years of age and under 64 at the time of enrollment."

Answered by AI

Am I eligible to become part of this research project?

"Patients with hidradenitis suppurativa who are between 18 and 64 years of age may be eligible for participation in this clinical trial. The total number of participants accepted into the study is 16 people."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Wake Forest School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I need help managing my HS.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Gentian Violet Treatment for Hidradenitis Suppurativa
2024. "Gentian Violet Treatment for Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04388163.
All > Hidradenitis Suppurativa
~11 spots leftby Aug 2024
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