Trial Outcomes & Findings for Hidradenitis Suppurativa (HS) Tunneling Wounds (NCT NCT04648631)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline, 4 weeks

Results posted on

2024-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Antibiofilm Surfactant Wound Gel (ABWG) The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hidradenitis Suppurativa (HS) Tunneling Wounds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks

Population: Only 8 patients of the 15 had with enough tissue sample for analysis.

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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=8 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change in Microbiome Baseline	5.46 colony forming units per ml (CFU/ml) Standard Deviation 1.85
Change in Microbiome 4 weeks	3.88 colony forming units per ml (CFU/ml) Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline, 4 week

Population: this was an oversight of the translation of the protocol to the CRF that resulted in the 4 week data point not collected.

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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change in Lesion Severity as Measured by HS-PGA Baseline	3.00 units on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Population: this was an oversight of the translation of the protocol to the CRF that resulted in the 4 week data point not collected.

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).

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change in Lesion Severity as Measured by the Hurley Stage Baseline	2.00 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Baseline, 4 weeks

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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change in Pain as Measured by VAS Baseline	1.40 units on a scale Interval 0.34 to 2.64
Change in Pain as Measured by VAS 4 weeks	0.96 units on a scale Interval 0.05 to 3.56

SECONDARY outcome

Timeframe: Baseline, 4 weeks

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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change HS Lesion Erythema Baseline	1.00 score on a scale Interval 0.0 to 3.0
Change HS Lesion Erythema 4 weeks	2.00 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Baseline, 4 weeks

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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change in Exudate Baseline	0.00 score on a scale Interval 0.0 to 2.0
Change in Exudate 4 weeks	0.00 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Population: Data for this outcome measure was not collected due to instrument needed for outcome measure was never received for the study, impeding the collection of this specific data point at both baseline and "4 weeks" timepoint.

As measured by goniometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Number of Participants With Decreased Pain Medication Use	4 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Number of Participants With Escalated Pain Medication Use	1 participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks

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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change in Number of Days of Work/School Lost Baseline	0.00 Days Interval 0.0 to 2.0
Change in Number of Days of Work/School Lost 4 weeks	0.00 Days Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 4 weeks

As reported by participants

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Number of Dressings Used	13.00 number of dressings Interval 0.0 to 20.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change in Quality of Life as Measured by HiSQOL Baseline	44.00 score on a scale Standard Deviation 14.04
Change in Quality of Life as Measured by HiSQOL 4 weeks	44.80 score on a scale Standard Deviation 20.41

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 Participants The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. Antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel that will be applied topically to both punch sites using a tongue depressor. In the days between visits, patients will apply one fingertip unit of the ABWG to the study wound daily.
Change in Quality of Life as Measured by DLQI Baseline	12.00 score on a scale Interval 2.0 to 30.0
Change in Quality of Life as Measured by DLQI 4 weeks	8.00 score on a scale Interval 0.0 to 25.0

Adverse Events

Antibiofilm Surfactant Wound Gel (ABWG)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Antibiofilm Surfactant Wound Gel (ABWG) n=15 participants at risk The participants in this group will be receiving the ABWG daily for 4 consecutive weeks. antibiofilm surfactant wound gel (ABWG): ABWG is a hydro-gel applied topically using a tongue depressor
Skin and subcutaneous tissue disorders Stinging	40.0% 6/15 • Number of events 6 • 1 month

Additional Information

Hadar Lev-Tov, MD

University of Miami

Phone: 305-689-2646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place