Hidradenitis SuppurativaNCT04648631
Hidradenitis Suppurativa (HS) Tunneling Wounds
A study testing antibiofilm surfactant wound gel (ABWG) in people with Hidradenitis Suppurativa, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to look at the change in the microbiome (bacterial composition) of an HS tunneling wound and examine if treatment with an antibiofilm surfactant wound gel (ABWG) (a topical medication that will fight bacteria attached to the surface of those tunnels) changes the bacterial composition of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- antibiofilm surfactant wound gel (ABWG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years old and older
- Have diagnosis of HS confirmed by a dermatologist
- Have at least one HS related tunneling wound that is at least 2 centimeters in length
- Able to provide informed consent
Who cannot join
- Individuals who are not yet adults
- Women known to be pregnant
- Prisoners
- Subjects, who in the opinion of the PI, cannot comply with home application of the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds
The purpose of this study is to look at the change in the microbiome (bacterial composition) of an HS tunneling wound and examine if treatment with an antibiofilm surfactant wound gel (ABWG) (a topical medication that will fight bacteria attached to the surface of those tunnels) changes the bacterial composition of the wounds.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- antibiofilm surfactant wound gel (ABWG)
- Keywords
- tunneling wound
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiofilm surfactant wound gel (ABWG)Device
ABWG is a hydro-gel applied topically using a tongue depressor
| Study group | Role | What they receive |
|---|---|---|
| ABWG | Experimental | The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Receives: Device: antibiofilm surfactant wound gel (ABWG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Microbiome
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
Measured: Baseline, 4 weeks
Secondary outcomes (12)
Change in Lesion Severity as Measured by HS-PGA
HS Physician's Global Assessment (HS-PGA) Scale is a 6 point Likert scale from 0 (clear) to 5 (very severe)
Measured: Baseline, 4 week
Change in Lesion Severity as Measured by the Hurley Stage
The Hurley score is staged as: 1 (single or multiple abscesses without sinus tract formation or scarring); 2 (recurrent abscesses with one or more sinus tracts and scarring widely separated by normal skin); 3 (diffuse involvement with multiple sinus tracts and no intervening normal skin).
Measured: Baseline, 4 weeks
Change in Pain as Measured by VAS
Visual Analog Scale (VAS) has a total score ranging from 0 to 10 with the higher score indicating greater pain.
Measured: Baseline, 4 weeks
Change HS Lesion Erythema
As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).
Measured: Baseline, 4 weeks
Change in Exudate
Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).
Measured: Baseline, 4 weeks
Change in Range of Motion
As measured by goniometer
Measured: Baseline, 4 weeks
Number of Participants With Decreased Pain Medication Use
Pain medication use will be reported as the number of participants that reports a decrease in the dose and/or frequency of pain medication use
Measured: 4 weeks
Number of Participants With Escalated Pain Medication Use
Pain medication use will be reported as the number of participants that reports an escalation from using Non-steroidal Anti-inflammatory Drugs (NSAIDs)/acetaminophen to opioids
Measured: 4 weeks
Change in Number of Days of Work/School Lost
As self-reported by participants the number of days missed over the length of the study.
Measured: Baseline, 4 weeks
Number of Dressings Used
As reported by participants
Measured: 4 weeks
Change in Quality of Life as Measured by HiSQOL
HS quality of life (HiSQOL) has a total score ranging from 0 to 68, with higher scores indicating more severe impact on participant's quality of life
Measured: Baseline, 4 weeks
Change in Quality of Life as Measured by DLQI
Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start26 Feb 2021
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Next Science LLC
- Responsible party
- Principal investigator, Hadar Lev-Tov, University of Miami
- Investigators
- Hadar Lev-Tov, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648631
- Sponsor's protocol ID
- 20201035
- Status last verified
- Mar 2024
- First submitted
- 23 Nov 2020
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds
- ClinicalTrials.gov ID
- NCT04648631
- Acronym / sponsor ID
- 20201035
- Conditions
- Hidradenitis Suppurativa
- Keywords
- tunneling wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Next Science LLC
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the change in the microbiome (bacterial composition) of an HS tunneling wound and examine if treatment with an antibiofilm surfactant wound gel (ABWG) (a topical medication that will fight bacteria attached to the surface of those tunnels) changes the bacterial composition of the wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABWG | Experimental | Device: antibiofilm surfactant wound gel (ABWG)The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 years old and older
- Have diagnosis of HS confirmed by a dermatologist
- Have at least one HS related tunneling wound that is at least 2 centimeters in length
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Individuals who are not yet adults
- Women known to be pregnant
- Prisoners
- Subjects, who in the opinion of the PI, cannot comply with home application of the treatment.
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 |
|---|---|---|
| antibiofilm surfactant wound gel (ABWG)ABWG is a hydro-gel applied topically using a tongue depressor | Device | ABWG |
Primary outcome
Change in Microbiome
Time frame: Baseline, 4 weeks
As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.
12 secondary outcomes
Change in Lesion Severity as Measured by HS-PGA
Time frame: Baseline, 4 week
Change in Lesion Severity as Measured by the Hurley Stage
Time frame: Baseline, 4 weeks
Change in Pain as Measured by VAS
Time frame: Baseline, 4 weeks
Change HS Lesion Erythema
Time frame: Baseline, 4 weeks
Change in Exudate
Time frame: Baseline, 4 weeks
Change in Range of Motion
Time frame: Baseline, 4 weeks
Number of Participants With Decreased Pain Medication Use
Time frame: 4 weeks
Number of Participants With Escalated Pain Medication Use
Time frame: 4 weeks
Change in Number of Days of Work/School Lost
Time frame: Baseline, 4 weeks
Number of Dressings Used
Time frame: 4 weeks
Change in Quality of Life as Measured by HiSQOL
Time frame: Baseline, 4 weeks
Change in Quality of Life as Measured by DLQI
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hadar Lev-Tov, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiofilm surfactant wound gel (ABWG) in people with Hidradenitis Suppurativa, run by University of Miami 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 2 Apr 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Microbiome (time frame: Baseline, 4 weeks). 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 2 Apr 2024.