Gentian Violet for Hidradenitis Suppurativa

Overseen ByIrma M Richardson, MHA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Children, Cognitive/physical impairments, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on applying gentian violet and assessing its effects.

Is gentian violet safe for use in humans?

Gentian violet is generally safe for external use, with no serious side effects reported when applied to the skin. However, it can cause gastrointestinal irritation if taken orally and has been linked to cancer in animal studies. It is important to ensure that gentian violet solutions are sterile to avoid infections.¹ ² ³ ⁴ ⁵

How is the drug gentian violet unique in treating hidradenitis suppurativa?

Gentian violet is unique because it has antibacterial and antifungal properties, and it has been effective in eradicating methicillin-resistant Staphylococcus aureus (MRSA) from skin lesions, which is a common issue in hidradenitis suppurativa. Unlike some other treatments, it is inexpensive, well-tolerated, and can be applied topically, making it a practical option for managing skin infections.¹ ² ³ ⁶ ⁷

What is the purpose of this trial?

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.

Research Team

Rita Pichardo-Geisinger, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

Inclusion Criteria

I have active HS and agree to one treatment and a follow-up in a month.

Exclusion Criteria

I can understand and respond to questions about my quality of life.

I do not have any active skin lesions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A single application of gentian violet is topically applied to the site(s) of active HS involvement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in skin drainage, redness, and pain post-treatment

4 weeks

Treatment Details

Interventions

Gentian Violet

Trial Overview 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.

Participant Groups

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.