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This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic Saline | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 23.4% Hypertonic saline | Drug | Saline Injections |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and visit 4 (week 8) |
| Numeric Rating Scale for Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martina Porter, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic data was measured for all pariticipants, outcome measures were measured for only 17 completed subjects who had data for all visits. Physician assessment were only reported for 16sujbects
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 16 subjects completed the study and had percent score data for Baseline and Visit 4 comparison | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
Adverse events were collected for 8 weeks for each subject.
Definition doe snot differ, expected adverse events listed in the ICF were not collected or reported as per institution IRB guidelines
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Study limitations include 1) small sample size and lack of a control group. 2) the lack of an established scoring system for assessing improvement in individual fistulas. 3) We were unable to determine full fistula dimensions over time with ultrasound. 4) This was a single team of clinical investigators; therefore, treatment efficacy cannot be assessed between study investigators who were not trained by the original investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martina Porter - Associate Directory of Dermatology Research | Beth Israel Deaconess Medical Center | 6176675834 | mporter3@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2019 | Feb 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 23, 2018 | Feb 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
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| Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | 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). |
| Baseline and visit 4 (week 8) |
| Length of Fistula | Measuring the length and the lumen of the fistulas using ultrasound if possible. | Baseline and visit 4 (week 8) |
| 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. | Baseline and visit 4 (week 8) |
| 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. | Baseline to Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| 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. | Baseline and Visit 4 (week 8) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
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|
| 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). | Median score for Baseline and Visit 4 visits for 15 subjects who completed both visits. | Posted | Median | Standard Deviation | score on a scale | Baseline and visit 4 (week 8) |
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| 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). | Baseline and Visit 4 pain scores were analyzed for 15 subjects who reported data for both visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline and visit 4 (week 8) |
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| Secondary | Length of Fistula | Measuring the length and the lumen of the fistulas using ultrasound if possible. | 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. | Posted | Baseline and visit 4 (week 8) |
|
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| 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. | DLQI score for subjects who had data for baseline and visit 4 (final visit) | Posted | Mean | Standard Deviation | score on a scale | Baseline and visit 4 (week 8) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline to Visit 4 (week 8) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline and Visit 4 (week 8) |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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