Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

• ClinicalTrials.gov Identifier: NCT02805595
• Recruitment Status: Completed
• First Posted: June 20, 2016
• Last Update Posted: January 9, 2023
• Sponsor: Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Martina Porter, Beth Israel Deaconess Medical Center

Tracking Information

• First Submitted Date: June 10, 2016
• First Posted Date: June 20, 2016
• Last Update Posted Date: January 9, 2023
• Actual Study Start Date: August 2016
• Actual Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 6, 2023)

HS Physician Local Improvement assessment [ Time Frame: Baseline and 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'.

Original Primary Outcome Measures (submitted: June 15, 2016)

• Fistula/Sinus Tract Length [ Time Frame: 8 weeks ]
  The clinical efficacy will be assessed by measuring change in length of the fistulas and/or sinus tracts using ultrasound from baseline at week 8.
• Fistula/Sinus Tract Lumen Diameter [ Time Frame: 8 weeks ]
  The clinical efficacy will be assessed by measuring change in diameter of the lumen of the fistulas and/or sinus tracts using ultrasound from baseline at week 8.

Current Secondary Outcome Measures (submitted: January 6, 2023)

• Numeric Rating Scale for Stinging [ Time Frame: Baseline and visit 8 ]
  Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
• Numeric Rating Scale for Pain [ Time Frame: Baseline and visit 8 ]
  Self-reported median pain and stinging intensity during and directly after treatment with Hypertonic saline injections.
• Length of fistula [ Time Frame: Baseline and visit 8 ]
  Measuring the length and the lumen of the fistulas using ultrasound if possible.
• Dermatology Life Quality Index [ Time Frame: Baseline to Visit 8 ]
  Mean score patient-reported outcomes based on Dermatology Life Quality Index (DLQI).
• HS Patient Local Improvement assessment [ Time Frame: Baseline to Visit 8 ]
  Percentage change in Patient improvement assessment about state of the disease over the last 24hours.

Original Secondary Outcome Measures (submitted: June 15, 2016)

• Improvement Assessment [ Time Frame: 8 weeks ]
  This non-validated assessment is based on the Clinical Global Impression (CGI) scale and allows the physician and the subject to score multiple hidradenitis suppurativa (HS) symptoms on a scale from 'extremely worse' to 'very much improved' compared to baseline.
• Numeric Rating Scale for Pain/Stinging [ Time Frame: 1 hour ]
  Self-reported pain and stinging intensity during and directly after treatment with Hypertonic saline injections.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa
• Official Title: A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa
• Brief Summary: This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hidradenitis Suppurativa

Intervention

Drug: 23.4% Hypertonic saline

Saline Injections

Other Name: 23.4% sodium chloride

Study Arms

Experimental: 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.

Intervention: Drug: 23.4% Hypertonic saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 6, 2023): 21
• Original Estimated Enrollment (submitted: June 15, 2016): 20
• Actual Study Completion Date: November 2022
• Actual Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02805595
• Other Study ID Numbers: 2016P001274
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Martina Porter, Beth Israel Deaconess Medical Center
• Original Responsible Party: Alexandra Kimball, Massachusetts General Hospital, Director, Clinical Unit for Research Trials and Outcomes in Skin
• Current Study Sponsor: Beth Israel Deaconess Medical Center
• Original Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Martina Porter, MD; Beth Israel Deaconess Medical Center

• PRS Account: Beth Israel Deaconess Medical Center
• Verification Date: January 2023