NCT04648631

Hidradenitis Suppurativa (HS) Tunneling Wounds

Completed NA Results posted Last updated 2 April 2024

What this trial tests

NA trial testing antibiofilm surfactant wound gel (ABWG) in Hidradenitis Suppurativa in 15 participants. Completed in 28 July 2022.

Timeline

26 February 2021

Primary endpoint
28 July 2022

28 July 2022

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	26 February 2021
Primary completion	28 July 2022
Estimated completion	28 July 2022
Sites	1 location across United States

Drugs / interventions tested

• antibiofilm surfactant wound gel (ABWG)

Conditions studied

• Hidradenitis Suppurativa — all drugs for Hidradenitis Suppurativa →

Sponsor

University of Miami

Who can join

18 and older, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Microbiome Primary · Baseline, 4 weeks

As measured by quantitative 16s rDNA Polymerase Chain Reaction for bacterial enumeration from punch biopsy samples.

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	5.46	± 1.85

4 weeks

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	3.88	± 1.09

Change in Lesion Severity as Measured by HS-PGA Secondary · Baseline, 4 week

HS Physician's Global Assessment (HS-PGA) Scale is a 6 point Likert scale from 0 (clear) to 5 (very severe)

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	3.00	2.00 – 5.00

Change in Lesion Severity as Measured by the Hurley Stage Secondary · Baseline, 4 weeks

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).

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	2.00	2.00 – 3.00

Change in Pain as Measured by VAS Secondary · Baseline, 4 weeks

Visual Analog Scale (VAS) has a total score ranging from 0 to 10 with the higher score indicating greater pain.

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	1.40	0.34 – 2.64

4 weeks

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	0.96	0.05 – 3.56

Change HS Lesion Erythema Secondary · Baseline, 4 weeks

As measured the Clinician Erythema Assessment (CEA) scale. CEA scale ranges from 0 (clear) to 4 (severe).

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	1.00	0.00 – 3.00

4 weeks

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	2.00	0.00 – 3.00

Change in Exudate Secondary · Baseline, 4 weeks

Exudate will be evaluated using a 5 point Likert scale from 0 (Dry) to 4 (Leaking).

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	0.00	0.00 – 2.00

4 weeks

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	0.00	0.00 – 2.00

Number of Participants With Decreased Pain Medication Use Secondary · 4 weeks

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

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	4

Number of Participants With Escalated Pain Medication Use Secondary · 4 weeks

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

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	1

Change in Number of Days of Work/School Lost Secondary · Baseline, 4 weeks

As self-reported by participants the number of days missed over the length of the study.

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	0.00	0.00 – 2.00

4 weeks

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	0.00	0.00 – 3.00

Number of Dressings Used Secondary · 4 weeks

As reported by participants

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	13.00	0.00 – 20.00

Change in Quality of Life as Measured by HiSQOL Secondary · Baseline, 4 weeks

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

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	44.00	± 14.04

4 weeks

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	44.80	± 20.41

Change in Quality of Life as Measured by DLQI Secondary · Baseline, 4 weeks

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

Baseline

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	12.00	2.00 – 30.00

4 weeks

Group	Value	95% CI
Antibiofilm Surfactant Wound Gel (ABWG)	8.00	0.00 – 25.00

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Antibiofilm Surfactant Wound Gel (ABWG)

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Antibiofilm Surfactant Wou…
Stinging	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04648631 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.