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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 below

Select...

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

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

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 • 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

Blood uric acid increased

Blood phosphorus decreased

Blood potassium decreased

Cough

Pulmonary tuberculosis

Cheilitis

Chest pain

Stomatitis

Blood creatinine increased

Blood glucose increased

Oropharyngeal plaque

Diarrhoea

Leukoplakia oral

Odynophagia

Oral mucosal erythema

Oral hairy leukoplakia

Pneumonia bacterial

Pyrexia

Death

Gastroenteritis

Anaemia

Pneumonia

Oesophageal candidiasis

Renal failure acute

HIV infection WHO clinical stage IV

Haemoptysis

Blood glucose decreased

Encephalitis viral

Meningitis cryptococcal

Cerebrovascular accident

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met