Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa
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|ClinicalTrials.gov Identifier: NCT02805595|
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : January 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Drug: 23.4% Hypertonic saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||November 2022|
|Actual Study Completion Date :||November 2022|
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.
Drug: 23.4% Hypertonic saline
Other Name: 23.4% sodium chloride
- 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'.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805595
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Martina Porter, MD||Beth Israel Deaconess Medical Center|
|Responsible Party:||Martina Porter, Instructor in Dermatology, Beth Israel Deaconess Medical Center|
|Other Study ID Numbers:||
|First Posted:||June 20, 2016 Key Record Dates|
|Last Update Posted:||January 9, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Pathological Conditions, Anatomical
Sweat Gland Diseases
Skin Diseases, Bacterial
Bacterial Infections and Mycoses
Skin Diseases, Infectious