Hidradenitis SuppurativaPhase 2NCT04388163
Gentian Violet Treatment for Hidradenitis Suppurativa
A Phase 2 study testing Gentian Violet in people with Hidradenitis Suppurativa, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Gentian Violet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have active HS, be willing to undergo one application of HS, and agree to follow-up in one month.
Who cannot join
- Exclusion criteria include children, absent HS lesions at the time of clinic, and cognitive/physical impairments that would make them unable to assess quality of life factors of the survey.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa
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.
Read the detailed description
Hidradenitis suppurativa (HS) is a chronic disease of the folliculopilosebaceous unit, often found in intertriginous areas of the body. The pain and impairment of HS leads patients to report a decreased quality of life, even in comparison to other debilitating cutaneous disease states. Pharmalogic management of HS can vary from topical antibiotics or intralesional corticosteroids for mild cases to immunosuppressants and biologic agents in refractory cases. 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 ulceration. It is our hypothesis that gentian violet will help minimize skin trauma in sites of active HS to promote improved wound healing and quality of life.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Gentian Violet
- Keywords
- HS, Gentian Violet, nonsurgical treatment
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentian VioletDrug
Also called crystal violet
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 ulceration.
| Study group | Role | What they receive |
|---|---|---|
| Gentian Violet Treatment | Experimental | 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. Receives: Drug: Gentian Violet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin's Redness
Subjects rate site redness on a scale from 1 (no redness) to 5 (severe redness)
Measured: baseline pre-treatment
Skin's Redness
Subjects rate skin redness at treatment site on a scale from 1 (no redness) to 5 (severe redness)
Measured: 1 month post-treatment
Skin's Drainage
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Measured: baseline pre-treatment
Skin's Drainage
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Measured: 1 month post-treatment
Skin's Pain
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Measured: baseline pre-treatment
Skin's Pain
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Measured: 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study startAug 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Drug company did not approve use of the drug, IRB never approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Pichardo-Geisinger, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388163
- Sponsor's protocol ID
- IRB00063737
- Status last verified
- Aug 2025
- First submitted
- 11 May 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04388163
- Acronym / sponsor ID
- IRB00063737
- Conditions
- Hidradenitis Suppurativa
- Keywords
- HS, Gentian Violet, nonsurgical treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug company did not approve use of the drug, IRB never approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hidradenitis suppurativa (HS) is a chronic disease of the folliculopilosebaceous unit, often found in intertriginous areas of the body. The pain and impairment of HS leads patients to report a decreased quality of life, even in comparison to other debilitating cutaneous disease states. Pharmalogic management of HS can vary from topical antibiotics or intralesional corticosteroids for mild cases to immunosuppressants and biologic agents in refractory cases. 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 ulceration. It is our hypothesis that gentian violet will help minimize skin trauma in sites of active HS to promote improved wound healing and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gentian Violet Treatment | Experimental | Drug: Gentian VioletA 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 may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients must have active HS, be willing to undergo one application of HS, and agree to follow-up in one month.
Key exclusion criteria (1 listed)
- Exclusion criteria include children, absent HS lesions at the time of clinic, and cognitive/physical impairments that would make them unable to assess quality of life factors of the survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentian VioletAlso: crystal violetGentian 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 ulceration. | Drug | Gentian Violet Treatment |
Primary outcome
Skin's Redness
Time frame: baseline pre-treatment
Subjects rate site redness on a scale from 1 (no redness) to 5 (severe redness)
Skin's Redness
Time frame: 1 month post-treatment
Subjects rate skin redness at treatment site on a scale from 1 (no redness) to 5 (severe redness)
Skin's Drainage
Time frame: baseline pre-treatment
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Skin's Drainage
Time frame: 1 month post-treatment
Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)
Skin's Pain
Time frame: baseline pre-treatment
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Skin's Pain
Time frame: 1 month post-treatment
Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Pichardo-Geisinger, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gentian Violet in people with Hidradenitis Suppurativa, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin's Redness (time frame: baseline pre-treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.