Hidradenitis Suppurativa
Conditions
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.
Interventions
DRUG23.4% Hypertonic saline
Saline Injections
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HS Physician Local Improvement Assessment - PAIN | 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. |
| HS Physician Local Improvement Assessment - Fluid Leakage From Fistula | 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. |
| HS Physician Local Improvement Assessment - Erythema | 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. |
| HS Physician Local Improvement Assessment - Tenderness | 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. |
| HS Physician Local Improvement Assessment - Swelling | 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. |
| HS Physician Local Improvement Assessment - Hardness of Skin | 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. |
| HS Physician Local Improvement Assessment - Hotness of Skin | 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. |
| HS Physician Local Improvement Assessment - Odor | 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
| Measure | Time frame | Description |
|---|---|---|
| HS Patient Local Improvement Assessment - Swelling | 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. |
| HS Patient Local Improvement Assessment - Hardness of Skin | 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. |
| Numeric Rating Scale for Stinging | 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). |
| HS Patient Local Improvement Assessment - Odor | 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. |
| HS Patient Local Improvement Assessment - Hotness of Skin | 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. |
| Numeric Rating Scale for Pain | 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). |
| Length of Fistula | Baseline and visit 4 (week 8) | Measuring the length and the lumen of the fistulas using ultrasound if possible. |
| HS Patient Local Improvement Assessment - Erythema | 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. |
| Dermatology Life Quality Index | 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. |
| HS Patient Local Improvement Assessment - Pain | 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. |
| HS Patient Local Improvement Assessment - Fluid From Fistula | 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. |
| HS Patient Local Improvement Assessment - Tenderness | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
23.4% Hypertonic saline: Saline Injections | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Hypertonic Saline |
|---|---|
| Age, Continuous | 36.85 Years STANDARD_DEVIATION 13.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
HS Physician Local Improvement Assessment - Erythema
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Physician Local Improvement Assessment - Erythema | Improved | 11 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Erythema | No Change | 3 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Erythema | Worsened | 2 Participants |
Primary
HS Physician Local Improvement Assessment - Fluid Leakage From Fistula
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 15subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Physician Local Improvement Assessment - Fluid Leakage From Fistula | Improved | 9 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Fluid Leakage From Fistula | No Change | 5 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Fluid Leakage From Fistula | Worsened | 1 Participants |
Primary
HS Physician Local Improvement Assessment - Hardness of Skin
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Physician Local Improvement Assessment - Hardness of Skin | Improved | 4 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Hardness of Skin | No Change | 5 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Hardness of Skin | Worsened | 7 Participants |
Primary
HS Physician Local Improvement Assessment - Hotness of Skin
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Physician Local Improvement Assessment - Hotness of Skin | Improved | 3 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Hotness of Skin | No Change | 12 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Hotness of Skin | Worsened | 1 Participants |
Primary
HS Physician Local Improvement Assessment - Odor
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Physician Local Improvement Assessment - Odor | Improved | 5 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Odor | No Change | 10 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Odor | Worsened | 1 Participants |
Primary
HS Physician Local Improvement Assessment - PAIN
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16 subjects completed the study and had percent score data for Baseline and Visit 4 comparison
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Physician Local Improvement Assessment - PAIN | Improved | 7 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - PAIN | No Change | 7 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - PAIN | Worsened | 2 Participants |
Primary
HS Physician Local Improvement Assessment - Swelling
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Physician Local Improvement Assessment - Swelling | Improved | 10 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Swelling | No Change | 5 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Swelling | Worsened | 1 Participants |
Primary
HS Physician Local Improvement Assessment - Tenderness
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Physician Local Improvement Assessment - Tenderness | Improved | 7 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Tenderness | No Change | 6 Participants |
| Hypertonic Saline | HS Physician Local Improvement Assessment - Tenderness | Worsened | 3 Participants |
Secondary
Dermatology Life Quality Index
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.
Time frame: Baseline and visit 4 (week 8)
Population: DLQI score for subjects who had data for baseline and visit 4 (final visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypertonic Saline | Dermatology Life Quality Index | Baseline | 9.14 score on a scale | Standard Deviation 5.83 |
| Hypertonic Saline | Dermatology Life Quality Index | Visit 4 | 6.0 score on a scale | Standard Deviation 5.62 |
Secondary
HS Patient Local Improvement Assessment - Erythema
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Patient Local Improvement Assessment - Erythema | Improved | 13 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Erythema | No Change | 2 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Erythema | Worsened | 2 Participants |
Secondary
HS Patient Local Improvement Assessment - Fluid From Fistula
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Patient Local Improvement Assessment - Fluid From Fistula | Improved | 14 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Fluid From Fistula | No Change | 0 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Fluid From Fistula | Worsened | 3 Participants |
Secondary
HS Patient Local Improvement Assessment - Hardness of Skin
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Patient Local Improvement Assessment - Hardness of Skin | Improved | 10 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Hardness of Skin | No Change | 3 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Hardness of Skin | Worsened | 4 Participants |
Secondary
HS Patient Local Improvement Assessment - Hotness of Skin
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Patient Local Improvement Assessment - Hotness of Skin | Improved | 8 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Hotness of Skin | No Change | 8 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Hotness of Skin | Worsened | 0 Participants |
Secondary
HS Patient Local Improvement Assessment - Odor
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Patient Local Improvement Assessment - Odor | No Change | 3 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Odor | Improved | 10 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Odor | Worsened | 3 Participants |
Secondary
HS Patient Local Improvement Assessment - Pain
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.
Time frame: Baseline to Visit 4 (week 8)
Population: 16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Patient Local Improvement Assessment - Pain | Improved | 13 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Pain | no change | 1 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Pain | worsened | 2 Participants |
Secondary
HS Patient Local Improvement Assessment - Swelling
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Patient Local Improvement Assessment - Swelling | Improved | 15 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Swelling | No Change | 2 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Swelling | Worsened | 0 Participants |
Secondary
HS Patient Local Improvement Assessment - Tenderness
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.
Time frame: Baseline and Visit 4 (week 8)
Population: 17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hypertonic Saline | HS Patient Local Improvement Assessment - Tenderness | Improved | 15 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Tenderness | No Change | 1 Participants |
| Hypertonic Saline | HS Patient Local Improvement Assessment - Tenderness | Worsened | 1 Participants |
Secondary
Length of Fistula
Measuring the length and the lumen of the fistulas using ultrasound if possible.
Time frame: Baseline and visit 4 (week 8)
Population: Data was not analyzed or collected since measuring length of fistulas through ultrasound seemed not feasible. Measurement had to be taken from precise location at each visit for it to be accurate, but the fistula changed shape between visits which made is impossible to use these measures as an evaluation.
Secondary
Numeric Rating Scale for Pain
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).
Time frame: Baseline and visit 4 (week 8)
Population: Baseline and Visit 4 pain scores were analyzed for 15 subjects who reported data for both visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypertonic Saline | Numeric Rating Scale for Pain | Baseline | 3 score on a scale | Standard Deviation 2.14 |
| Hypertonic Saline | Numeric Rating Scale for Pain | Visit 4 | 6 score on a scale | Standard Deviation 2.54 |
Secondary
Numeric Rating Scale for Stinging
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).
Time frame: Baseline and visit 4 (week 8)
Population: Median score for Baseline and Visit 4 visits for 15 subjects who completed both visits.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Hypertonic Saline | Numeric Rating Scale for Stinging | Baseline | 5 score on a scale | Standard Deviation 2.4 |
| Hypertonic Saline | Numeric Rating Scale for Stinging | visit 4 | 5 score on a scale | Standard Deviation 2.7 |