Trial Outcomes & Findings for Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa (NCT NCT02805595)

NCT ID: NCT02805595

Last Updated: 2025-03-28

Results Overview

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline and Visit 4 (week 8)
• Results posted on: 2025-03-28

Participant Flow

Participant milestones

Measure	Hypertonic Saline 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
Overall Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

Baseline characteristics by cohort

Measure	Hypertonic Saline n=21 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments. 23.4% Hypertonic saline: Saline Injections
Age, Continuous	36.85 Years STANDARD_DEVIATION 13.41 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	5 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16 subjects completed the study and had percent score data for Baseline and Visit 4 comparison

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Physician Local Improvement Assessment - PAIN Improved	7 Participants
HS Physician Local Improvement Assessment - PAIN No Change	7 Participants
HS Physician Local Improvement Assessment - PAIN Worsened	2 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 15subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=15 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Physician Local Improvement Assessment - Fluid Leakage From Fistula Improved	9 Participants
HS Physician Local Improvement Assessment - Fluid Leakage From Fistula No Change	5 Participants
HS Physician Local Improvement Assessment - Fluid Leakage From Fistula Worsened	1 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Physician Local Improvement Assessment - Erythema Improved	11 Participants
HS Physician Local Improvement Assessment - Erythema No Change	3 Participants
HS Physician Local Improvement Assessment - Erythema Worsened	2 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Physician Local Improvement Assessment - Tenderness Improved	7 Participants
HS Physician Local Improvement Assessment - Tenderness No Change	6 Participants
HS Physician Local Improvement Assessment - Tenderness Worsened	3 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Physician Local Improvement Assessment - Swelling Improved	10 Participants
HS Physician Local Improvement Assessment - Swelling No Change	5 Participants
HS Physician Local Improvement Assessment - Swelling Worsened	1 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Physician Local Improvement Assessment - Hardness of Skin Improved	4 Participants
HS Physician Local Improvement Assessment - Hardness of Skin No Change	5 Participants
HS Physician Local Improvement Assessment - Hardness of Skin Worsened	7 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Physician Local Improvement Assessment - Hotness of Skin Improved	3 Participants
HS Physician Local Improvement Assessment - Hotness of Skin No Change	12 Participants
HS Physician Local Improvement Assessment - Hotness of Skin Worsened	1 Participants

PRIMARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Physician Local Improvement Assessment - Odor Improved	5 Participants
HS Physician Local Improvement Assessment - Odor No Change	10 Participants
HS Physician Local Improvement Assessment - Odor Worsened	1 Participants

SECONDARY outcome

Timeframe: Baseline and visit 4 (week 8)

Population: Median score for Baseline and Visit 4 visits for 15 subjects who completed both visits.

Self-reported median stinging intensity during and directly after treatment with Hypertonic saline injections.

Pain with a score of 1 (no stinging at all) to 10 (worst possible stinging).

Outcome measures

Measure	Hypertonic Saline n=15 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
Numeric Rating Scale for Stinging Baseline	5 score on a scale Standard Deviation 2.4
Numeric Rating Scale for Stinging visit 4	5 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline and visit 4 (week 8)

Population: Baseline and Visit 4 pain scores were analyzed for 15 subjects who reported data for both visits.

Self-reported median pain intensity during and directly after treatment with Hypertonic saline injections.

Pain with a score of 1 (no pain at all) to 10 (worst possible pain).

Outcome measures

Measure	Hypertonic Saline n=15 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
Numeric Rating Scale for Pain Baseline	3 score on a scale Standard Deviation 2.14
Numeric Rating Scale for Pain Visit 4	6 score on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: Baseline and visit 4 (week 8)

Population: Data was not analyzed or collected since measuring length of fistulas through ultrasound seemed not feasible. Measurement had to be taken from precise location at each visit for it to be accurate, but the fistula changed shape between visits which made is impossible to use these measures as an evaluation.

Measuring the length and the lumen of the fistulas using ultrasound if possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and visit 4 (week 8)

Population: DLQI score for subjects who had data for baseline and visit 4 (final visit)

Number of subjects improving based upon patient-reported outcomes The Dermatology Life Quality Index (DLQI) is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment)

The scoring of each question is as follows:

Very much scored = 3 points, A lot scored = 2 points, A little scored = 1, Not at all scored = 0 points, Not relevant scored = 0 points, Question 7, 'prevented work or studying' scored = 3 points. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 (meaning maximum impact on quality of life) and a minimum of 0 (meaning no impact of skin disease on quality of life). The higher the score, the more quality of life is impaired.

0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.

Outcome measures

Measure	Hypertonic Saline n=17 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
Dermatology Life Quality Index Baseline	9.14 score on a scale Standard Deviation 5.83
Dermatology Life Quality Index Visit 4	6.0 score on a scale Standard Deviation 5.62

SECONDARY outcome

Timeframe: Baseline to Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Patient Local Improvement Assessment - Pain Improved	13 Participants
HS Patient Local Improvement Assessment - Pain no change	1 Participants
HS Patient Local Improvement Assessment - Pain worsened	2 Participants

SECONDARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=17 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Patient Local Improvement Assessment - Fluid From Fistula Improved	14 Participants
HS Patient Local Improvement Assessment - Fluid From Fistula No Change	0 Participants
HS Patient Local Improvement Assessment - Fluid From Fistula Worsened	3 Participants

SECONDARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=17 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Patient Local Improvement Assessment - Erythema Improved	13 Participants
HS Patient Local Improvement Assessment - Erythema No Change	2 Participants
HS Patient Local Improvement Assessment - Erythema Worsened	2 Participants

SECONDARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=17 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Patient Local Improvement Assessment - Tenderness Improved	15 Participants
HS Patient Local Improvement Assessment - Tenderness No Change	1 Participants
HS Patient Local Improvement Assessment - Tenderness Worsened	1 Participants

SECONDARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=17 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Patient Local Improvement Assessment - Swelling Improved	15 Participants
HS Patient Local Improvement Assessment - Swelling No Change	2 Participants
HS Patient Local Improvement Assessment - Swelling Worsened	0 Participants

SECONDARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=17 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Patient Local Improvement Assessment - Hardness of Skin Improved	10 Participants
HS Patient Local Improvement Assessment - Hardness of Skin No Change	3 Participants
HS Patient Local Improvement Assessment - Hardness of Skin Worsened	4 Participants

SECONDARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Patient Local Improvement Assessment - Hotness of Skin Improved	8 Participants
HS Patient Local Improvement Assessment - Hotness of Skin No Change	8 Participants
HS Patient Local Improvement Assessment - Hotness of Skin Worsened	0 Participants

SECONDARY outcome

Timeframe: Baseline and Visit 4 (week 8)

Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.

Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'.

Patients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.

Outcome measures

Measure	Hypertonic Saline n=16 Participants 23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
HS Patient Local Improvement Assessment - Odor Improved	10 Participants
HS Patient Local Improvement Assessment - Odor No Change	3 Participants
HS Patient Local Improvement Assessment - Odor Worsened	3 Participants

Adverse Events

Hypertonic Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Martina Porter - Associate Directory of Dermatology Research

Beth Israel Deaconess Medical Center

Phone: 6176675834

Email: mporter3@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place