Phase 2
N=21
Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa
Hidradenitis Suppurativa
Bottom Line
View on ClinicalTrials.gov: NCT02805595 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: HS Physician Local Improvement Assessment - PAIN — 7; 7; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 23.4% Hypertonic saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HS Physician Local Improvement Assessment - PAIN |
7; 7; 2 | — |
| PRIMARY HS Physician Local Improvement Assessment - Fluid Leakage From Fistula |
9; 5; 1 | — |
| PRIMARY HS Physician Local Improvement Assessment - Erythema |
11; 3; 2 | — |
| PRIMARY HS Physician Local Improvement Assessment - Tenderness |
7; 6; 3 | — |
| PRIMARY HS Physician Local Improvement Assessment - Swelling |
10; 5; 1 | — |
| PRIMARY HS Physician Local Improvement Assessment - Hardness of Skin |
4; 5; 7 | — |
| PRIMARY HS Physician Local Improvement Assessment - Hotness of Skin |
3; 12; 1 | — |
| PRIMARY HS Physician Local Improvement Assessment - Odor |
5; 10; 1 | — |
| SECONDARY Numeric Rating Scale for Stinging |
5; 5 | — |
| SECONDARY Numeric Rating Scale for Pain |
3; 6 | — |
| SECONDARY Length of Fistula |
— | — |
| SECONDARY Dermatology Life Quality Index |
9.14; 6.0 | — |
| SECONDARY HS Patient Local Improvement Assessment - Pain |
13; 1; 2 | — |
| SECONDARY HS Patient Local Improvement Assessment - Fluid From Fistula |
14; 0; 3 | — |
| SECONDARY HS Patient Local Improvement Assessment - Erythema |
13; 2; 2 | — |
| SECONDARY HS Patient Local Improvement Assessment - Tenderness |
15; 1; 1 | — |
| SECONDARY HS Patient Local Improvement Assessment - Swelling |
15; 2; 0 | — |
| SECONDARY HS Patient Local Improvement Assessment - Hardness of Skin |
10; 3; 4 | — |
| SECONDARY HS Patient Local Improvement Assessment - Hotness of Skin |
8; 8; 0 | — |
| SECONDARY HS Patient Local Improvement Assessment - Odor |
10; 3; 3 | — |
Summary
This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.
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.
Data sourced from ClinicalTrials.gov (NCT02805595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.