Clinical trial NCT02805595: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: HS Physician Local Improvement Assessment - PAIN
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Physician Local Improvement Assessment - Fluid Leakage From Fistula
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Physician Local Improvement Assessment - Erythema
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Physician Local Improvement Assessment - Tenderness
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Physician Local Improvement Assessment - Swelling
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Physician Local Improvement Assessment - Hardness of Skin
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Physician Local Improvement Assessment - Hotness of Skin
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Physician Local Improvement Assessment - Odor
timeFrame: Baseline and Visit 4 (week 8)
Secondary outcomes:
measure: Numeric Rating Scale for Stinging
timeFrame: Baseline and visit 4 (week 8)
measure: Numeric Rating Scale for Pain
timeFrame: Baseline and visit 4 (week 8)
measure: Length of Fistula
timeFrame: Baseline and visit 4 (week 8)
measure: Dermatology Life Quality Index
timeFrame: Baseline and visit 4 (week 8)
measure: HS Patient Local Improvement Assessment - Pain
timeFrame: Baseline to Visit 4 (week 8)
measure: HS Patient Local Improvement Assessment - Fluid From Fistula
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Patient Local Improvement Assessment - Erythema
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Patient Local Improvement Assessment - Tenderness
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Patient Local Improvement Assessment - Swelling
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Patient Local Improvement Assessment - Hardness of Skin
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Patient Local Improvement Assessment - Hotness of Skin
timeFrame: Baseline and Visit 4 (week 8)
measure: HS Patient Local Improvement Assessment - Odor
timeFrame: Baseline and Visit 4 (week 8)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Martina Porter, MD
role: PRINCIPAL_INVESTIGATOR
References: