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Completed

NCT Number: NCT02805595

Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

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

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

23.4% Hypertonic saline

Drug

Saline Injections

Other names: 23.4% sodium chloride

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Numeric Rating Scale for Stinging

    Time frame: Baseline and visit 4 (week 8)

    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).

  2. Numeric Rating Scale for Pain

    Time frame: Baseline and visit 4 (week 8)

    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).

  3. Length of Fistula

    Time frame: Baseline and visit 4 (week 8)

    Measuring the length and the lumen of the fistulas using ultrasound if possible.

  4. Dermatology Life Quality Index

    Time frame: Baseline and visit 4 (week 8)

    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.

  5. HS Patient Local Improvement Assessment - Pain

    Time frame: Baseline to Visit 4 (week 8)

    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.

  6. HS Patient Local Improvement Assessment - Fluid From Fistula

    Time frame: Baseline and Visit 4 (week 8)

    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.

  7. HS Patient Local Improvement Assessment - Erythema

    Time frame: Baseline and Visit 4 (week 8)

    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.

  8. HS Patient Local Improvement Assessment - Tenderness

    Time frame: Baseline and Visit 4 (week 8)

    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.

  9. HS Patient Local Improvement Assessment - Swelling

    Time frame: Baseline and Visit 4 (week 8)

    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.

  10. HS Patient Local Improvement Assessment - Hardness of Skin

    Time frame: Baseline and Visit 4 (week 8)

    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.

  11. HS Patient Local Improvement Assessment - Hotness of Skin

    Time frame: Baseline and Visit 4 (week 8)

    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.

  12. HS Patient Local Improvement Assessment - Odor

    Time frame: Baseline and Visit 4 (week 8)

    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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 20, 2016
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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