Gentian Violet for Hidradenitis Suppurativa

Overseen By Irma 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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of gentian violet for individuals with hidradenitis suppurativa (HS), a condition causing painful lumps under the skin. Researchers aim to observe changes in skin appearance and collect participant feedback through surveys. Participants will receive a single application of gentian violet on their HS-affected areas, along with home care instructions. The trial seeks individuals with active HS who can attend a follow-up in one month. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early findings.

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 there any evidence suggesting that gentian violet is likely to be safe for humans?

Research has shown that gentian violet is generally safe when applied to the skin, with no serious side effects reported. However, swallowing it might cause stomach problems. Often used as a skin antiseptic to prevent infections, gentian violet may also help heal wounds.

Health Canada issued a safety alert about a possible cancer risk with gentian violet products, but this concern relates to long-term use, not the short-term use typical in most clinical settings. Evidence so far suggests that gentian violet is well-tolerated for skin use, which is the focus when treating hidradenitis suppurativa, a skin condition that causes lumps. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hidradenitis Suppurativa?

Gentian violet is unique because it offers a new approach to treating hidradenitis suppurativa (HS) with a topical application. Unlike many standard treatments like antibiotics or anti-inflammatory drugs, gentian violet is applied directly to the affected skin areas, potentially reducing systemic side effects. Researchers are excited about this treatment because gentian violet has antiseptic properties that could help manage bacterial involvement in HS, possibly leading to quicker and more localized relief.

What evidence suggests that gentian violet might be an effective treatment for Hidradenitis Suppurativa?

Research has shown that gentian violet, a topical medicine, might help treat Hidradenitis Suppurativa (HS). Known for its wound-cleaning and healing properties, early studies suggest it can reduce swelling and heal skin wounds in HS patients. While specific data on HS is still being gathered, gentian violet has successfully treated other skin issues due to its antibacterial and healing abilities. Ongoing research aims to understand its effectiveness for HS. Participants in this trial will receive a single application of gentian violet to the site(s) of active HS involvement. ^{3 4 6 7 8}

Who Is on the Research Team?

Rita Pichardo-Geisinger, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Gentian Violet Treatment Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04388163

Gentian Violet Treatment for Hidradenitis Suppurativa Study Overview​​ This is a survey study being conducted to describe how subjects with Hidradenitis suppurativa (HS) respond to treatment with gentian violet. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8613896/

New perspectives on the treatment of hidradenitis suppurativa A phase II open-label study is ongoing to evaluate the effect of topical gentian violet as an antiseptic and wound healing therapy in HS (NCT04388163). A phase ...

3. app.trialscreen.org app.trialscreen.org/trials/phase-2-hidradenitis-suppurativa-gentian-violet-treatment-trial-nct04388163

Gentian Violet Treatment for Hidradenitis Suppurativa The study aims to describe how individuals with Hidradenitis Suppurativa (HS) respond to treatment with gentian violet, a topical antiseptic.

4. withpower.com withpower.com/trial/phase-3-hidradenitis-10-2021-3798d

Gentian Violet for Hidradenitis Suppurativa This is a survey study being conducted to describe how subjects with Hidradenitis suppurativa (HS) respond to treatment with gentian violet.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10307738/

The Current Clinical Trial Landscape for Hidradenitis ... One of the secondary outcomes was HiSCR, and 63% of patients in group A and 61% of patients in group B achieved HiSCR at week 12. Possible ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04388163

Gentian Violet Treatment for Hidradenitis Suppurativa 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 ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04388163?recrs=abcdf&cond=Hidradenitis+Suppurativa&phase=1&fund=0123&draw=2&rank=1

Gentian Violet Treatment for Hidradenitis Suppurativa Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

8. hsa.gov.sg hsa.gov.sg/announcements/safety-alert/safety-update-on-gentian-violet-antiseptic

Safety update on gentian violet antiseptic In June 2019, Health Canada issued a safety alert on the potential risk of carcinogenicity with GV-containing products. The alert was based on ...