Hidradenitis SuppurativaPhase 2NCT02805595

Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

A Phase 2 study testing 23.4% Hypertonic saline in people with Hidradenitis Suppurativa, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa. 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?: 23.4% Hypertonic saline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Aug 2016to Nov 2022
Phase: Phase 2
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

Male or female subjects are at least 18 years of age or older
A confirmed diagnosis of HS disease
Presence of inflammatory HS lesion(s) and one or more fistula(s) or sinus tracts

Who cannot join

Receiving any other kind of treatment for fistulas including introduction of anti-inflammatory systemic therapy such as prednisone or adalimumab within the prior month.
Are participating in another study using an investigational agent or procedure during participation in this study.
Are currently pregnant or planning to get pregnant during the study.
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa

This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

Read the detailed description

The clinical effect of the hypertonic saline treatment will be evaluated with Physician Assessments at week 2 (t=2), week four (t=4) and week 8 (t=8) and compared with the first visit (baseline) (t=0). If necessary, subjects will be eligible to receive another hypertonic saline injected in week 2 and/or week 4, with a maximum of three injections. Simultaneously improvement will be assessed by ultrasound if possible, using the Philips Lumify Ultrasound Device, and by patients using HS Improvement Assessments. Pain and stinging during treatment sessions will be monitored using numeric rating scales (NRS). For monitoring quality of life the DLQI will be used.

Conditions: Hidradenitis Suppurativa
Being tested: 23.4% Hypertonic saline
Medical subject headings: Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

23.4% Hypertonic salineDrug
Also called 23.4% sodium chloride
Saline Injections

Study groups in NCT02805595
Study group	Role	What they receive
Hypertonic Saline	Experimental	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. Receives: Drug: 23.4% Hypertonic saline

What is being measured

The primary outcome is the main question the study is designed to answer.

HS Physician Local Improvement Assessment - PAIN
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.
Measured: Baseline and Visit 4 (week 8)
HS Physician Local Improvement Assessment - Fluid Leakage From Fistula
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.
Measured: Baseline and Visit 4 (week 8)
HS Physician Local Improvement Assessment - Erythema
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.
Measured: Baseline and Visit 4 (week 8)
HS Physician Local Improvement Assessment - Tenderness
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.
Measured: Baseline and Visit 4 (week 8)
HS Physician Local Improvement Assessment - Swelling
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.
Measured: Baseline and Visit 4 (week 8)
HS Physician Local Improvement Assessment - Hardness of Skin
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.
Measured: Baseline and Visit 4 (week 8)
HS Physician Local Improvement Assessment - Hotness of Skin
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.
Measured: Baseline and Visit 4 (week 8)
HS Physician Local Improvement Assessment - Odor
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.
Measured: Baseline and Visit 4 (week 8)

Secondary outcomes (12)

Numeric Rating Scale for Stinging
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).
Measured: Baseline and visit 4 (week 8)
Numeric Rating Scale for Pain
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).
Measured: Baseline and visit 4 (week 8)
Length of Fistula
Measuring the length and the lumen of the fistulas using ultrasound if possible.
Measured: Baseline and visit 4 (week 8)
Dermatology Life Quality Index
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.
Measured: Baseline and visit 4 (week 8)
HS Patient Local Improvement Assessment - Pain
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.
Measured: Baseline to Visit 4 (week 8)
HS Patient Local Improvement Assessment - Fluid From Fistula
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.
Measured: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Erythema
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.
Measured: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Tenderness
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.
Measured: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Swelling
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.
Measured: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Hardness of Skin
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.
Measured: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Hotness of Skin
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.
Measured: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Odor
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.
Measured: Baseline and Visit 4 (week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Nov 2022

First posted20 Jun 2016 (estimated)
Study startAug 2016
Primary completionNov 2022
Study completionNov 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 Beth Israel Deaconess Medical CenterThe 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: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02805595
Sponsor's protocol ID: 2016P001274
Status last verified: Mar 2025
First submitted: 10 Jun 2016
Last updated: 28 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

All Hidradenitis Suppurativa trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT02805595
Acronym / sponsor ID: 2016P001274
Conditions: Hidradenitis Suppurativa
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Study start: Aug 2016 (actual)
Primary completion: Nov 2022 (actual)
Study completion: Nov 2022 (actual)
First posted: 20 Jun 2016 (estimated)
Results: Posted 28 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hypertonic Saline	Experimental	Drug: 23.4% Hypertonic saline23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female subjects are at least 18 years of age or older
A confirmed diagnosis of HS disease
Presence of inflammatory HS lesion(s) and one or more fistula(s) or sinus tracts

Key exclusion criteria (4 listed)

Receiving any other kind of treatment for fistulas including introduction of anti-inflammatory systemic therapy such as prednisone or adalimumab within the prior month.
Are participating in another study using an investigational agent or procedure during participation in this study.
Are currently pregnant or planning to get pregnant during the study.
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

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
23.4% Hypertonic salineAlso: 23.4% sodium chlorideSaline Injections	Drug	Hypertonic Saline

Primary outcome

HS Physician Local Improvement Assessment - PAIN
Time frame: Baseline and Visit 4 (week 8)
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.
HS Physician Local Improvement Assessment - Fluid Leakage From Fistula
Time frame: Baseline and Visit 4 (week 8)
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.
HS Physician Local Improvement Assessment - Erythema
Time frame: Baseline and Visit 4 (week 8)
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.
HS Physician Local Improvement Assessment - Tenderness
Time frame: Baseline and Visit 4 (week 8)
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.
HS Physician Local Improvement Assessment - Swelling
Time frame: Baseline and Visit 4 (week 8)
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.
HS Physician Local Improvement Assessment - Hardness of Skin
Time frame: Baseline and Visit 4 (week 8)
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.
HS Physician Local Improvement Assessment - Hotness of Skin
Time frame: Baseline and Visit 4 (week 8)
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.
HS Physician Local Improvement Assessment - Odor
Time frame: Baseline and Visit 4 (week 8)
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.

12 secondary outcomes

Numeric Rating Scale for Stinging
Time frame: Baseline and visit 4 (week 8)
Numeric Rating Scale for Pain
Time frame: Baseline and visit 4 (week 8)
Length of Fistula
Time frame: Baseline and visit 4 (week 8)
Dermatology Life Quality Index
Time frame: Baseline and visit 4 (week 8)
HS Patient Local Improvement Assessment - Pain
Time frame: Baseline to Visit 4 (week 8)
HS Patient Local Improvement Assessment - Fluid From Fistula
Time frame: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Erythema
Time frame: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Tenderness
Time frame: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Swelling
Time frame: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Hardness of Skin
Time frame: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Hotness of Skin
Time frame: Baseline and Visit 4 (week 8)
HS Patient Local Improvement Assessment - Odor
Time frame: Baseline and Visit 4 (week 8)

Results and safety

Results posted to the registry on 28 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hypertonic Saline	21	17

Primary outcome: HS Physician Local Improvement Assessment - PAIN

Time frame: Baseline and Visit 4 (week 8). Count of participants. Unit: Participants

Measure	Hypertonic Saline n = 16
Improved	7
No Change	7
Worsened	2

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

Primary outcome: HS Physician Local Improvement Assessment - Fluid Leakage From Fistula

Time frame: Baseline and Visit 4 (week 8). Count of participants. Unit: Participants

Measure	Hypertonic Saline n = 15
Improved	9
No Change	5
Worsened	1

Population analysed: 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.

Primary outcome: HS Physician Local Improvement Assessment - Erythema

Time frame: Baseline and Visit 4 (week 8). Count of participants. Unit: Participants

Measure	Hypertonic Saline n = 16
Improved	11
No Change	3
Worsened	2

Population analysed: 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.

Primary outcome: HS Physician Local Improvement Assessment - Tenderness

Time frame: Baseline and Visit 4 (week 8). Count of participants. Unit: Participants

Measure	Hypertonic Saline n = 16
Improved	7
No Change	6
Worsened	3

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for 8 weeks for each subject.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hypertonic Saline	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): Study limitations include 1) small sample size and lack of a control group. 2) the lack of an established scoring system for assessing improvement in individual fistulas. 3) We were unable to determine full fistula dimensions over time with ultrasound. 4) This was a single team of clinical investigators; therefore, treatment efficacy cannot be assessed between study investigators who were not trained by the original investigators.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hidradenitis Suppurativa

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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Active, not recruitingPhase 2
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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.

Martina Porter, MD principal investigator

Beth Israel Deaconess Medical Center

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 23.4% Hypertonic saline in people with Hidradenitis Suppurativa, run by Beth Israel Deaconess Medical Center 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 3 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 28 Mar 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?

Yes. Results are posted in the registry (first posted 28 Mar 2025). 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?

HS Physician Local Improvement Assessment - PAIN (time frame: Baseline and Visit 4 (week 8)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02805595.

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 28 Mar 2025.