Brief Summary
Currently, there is limited evidence showing increased resolution of HS flares with higher doses of intralesional triamcinolone (ILTAC) as well as a difference in side effect profile between the doses. The goal of this study is to determine the efficacy of treating HS flares with ILTAC-10, ILTAC-20 and ILTAC-40 and to investigate the side effect profile for each dose.
Brief Title
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Detailed Description
A double-blinded, randomized, placebo-controlled study examining the relative efficacy of ILTAC-10, ILTAC-20, and ILTAC-40 versus placebo for acute flares of HS in subjects with moderate to severe HS. The duration of the study will be approximately 4 weeks for each enrolled patient and will include an initial screening/randomization/treatment visit and a 4-week follow-up period. During the initial visit, subjects who meet the study's eligibility criteria will be randomized to receive either ILTAC-10, ILTAC-20, ILTAC-40, or placebo in a 1:1:1:1 ratio. Study subjects will then receive treatment or placebo. The follow-up period will be of 4 weeks and will consist of 3 phone calls and 1 live visit, including an end of study visit on week 4 after randomization.
Completion Date
Completion Date Type
Actual
Conditions
Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria:
* Age \> 13 years old.
* Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board.
* Subject is willing to comply with the procedures in this protocol.
* The subject must be diagnosed with HS and receiving care at HSC
* Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5
* The subject must have an inflamed nodule or abscess at the time of enrollment.
Exclusion Criteria:
* The subject has an HS-PGA score of 0 or 1
* The subject has received ILTAC less than 8 days prior to the initial visit.
* The subject does not have capacity to consent to the study.
* The subject is has taken systemic steroids at least 4 weeks prior to the time of enrollment.
* The subject has a known allergy or history of adverse reaction to steroids.
* The subject is pregnant.
* Subjects who have received a biologic therapy two weeks before and during the study period.
* Age \> 13 years old.
* Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board.
* Subject is willing to comply with the procedures in this protocol.
* The subject must be diagnosed with HS and receiving care at HSC
* Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5
* The subject must have an inflamed nodule or abscess at the time of enrollment.
Exclusion Criteria:
* The subject has an HS-PGA score of 0 or 1
* The subject has received ILTAC less than 8 days prior to the initial visit.
* The subject does not have capacity to consent to the study.
* The subject is has taken systemic steroids at least 4 weeks prior to the time of enrollment.
* The subject has a known allergy or history of adverse reaction to steroids.
* The subject is pregnant.
* Subjects who have received a biologic therapy two weeks before and during the study period.
Inclusion Criteria
Inclusion Criteria:
* Age \> 13 years old.
* Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board.
* Subject is willing to comply with the procedures in this protocol.
* The subject must be diagnosed with HS and receiving care at HSC
* Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5
* The subject must have an inflamed nodule or abscess at the time of enrollment.
* Age \> 13 years old.
* Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board.
* Subject is willing to comply with the procedures in this protocol.
* The subject must be diagnosed with HS and receiving care at HSC
* Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5
* The subject must have an inflamed nodule or abscess at the time of enrollment.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
13 Years
NCT Id
NCT04582669
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-12227
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Primary Outcomes
Outcome Description
Numeric Rating Scale is a pain scale scored with whole integers from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable". Higher score indicates worse pain.
Outcome Measure
Change From Baseline in Numeric Rating Scale (NRS)
Outcome Time Frame
Baseline, Days 2, 6, 14, and 28
Secondary Outcomes
Outcome Description
HS-PGA is a six-staged physician global assessment tool (score ranges from 0 to 5) based on number of HS lesions including inflammatory and/or non-inflammatory nodules, abscesses, and draining fistulas. Higher HS-PGA score indicates more severe HS disease.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score
Outcome Description
CRP (measured in mg/dL) is an inflammatory marker. A higher value is correlated with more severe disease.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Change From Baseline in C-reactive Protein (CRP)
Outcome Description
HS lesion size will be measured using a metric ruler in centimeters. Measurement will be standardized according to greatest diameter as lesions will be measured from edge of one border to the edge of the opposite border.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size
Outcome Description
Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered outcome measures that assesses physical, mental, and psychosocial health in adults and children. Clinical measures of health outcome includes physical function, mobility, pain, fatigue, emotional stress, ability to participate in social roles, sleep-related impairment, depressive symptoms/sadness, anxiety/fear, and anger. The scores are rated on a scale from 0 to 100 with "0" being "best functioning" and "100" being "worst functioning".
Outcome Time Frame
Baseline, Days 2, 6, 14, and 28
Outcome Measure
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)
Outcome Description
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome Time Frame
Baseline
Outcome Measure
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Outcome Description
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome Time Frame
Day 2
Outcome Measure
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Outcome Description
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome Time Frame
Day 6
Outcome Measure
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Outcome Description
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome Time Frame
Day 14
Outcome Measure
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Outcome Description
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome Time Frame
Day 28
Outcome Measure
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Outcome Description
ESR (measured in mm/h), is a pro-inflammatory marker. Higher ESR levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Outcome Description
Likert scale is a rating system that is designed to measure participant's overall attitude and perception regarding one's health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.
Outcome Time Frame
Baseline
Outcome Measure
Baseline Patient Satisfaction Likert Scale
Outcome Description
Likert scale is a rating system that is designed to measure participant's overall attitude and perception regarding one's health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.
Outcome Time Frame
Days 2, 6, 14, and 28
Outcome Measure
Change From Baseline in Patient Satisfaction Likert Scale
Outcome Description
IL-6 (measured in pg/mL), is a pro-inflammatory cytokine. Higher IL-6 levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Change From Baseline in Interleukin-6 (IL-6)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
13
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Cohen
Investigator Email
srcohen@montefiore.org
Investigator Phone
917-817-9696
Categories Mesh Debug
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
MeSH Terms
HIDRADENITIS SUPPURATIVA
SKIN DISEASES, BACTERIAL
BACTERIAL INFECTIONS
BACTERIAL INFECTIONS AND MYCOSES
INFECTIONS
SKIN DISEASES, INFECTIOUS
SUPPURATION
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
HIDRADENITIS
SWEAT GLAND DISEASES
COUNTERFEIT DRUGS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS