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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
Steven Cohen
The Bronx, New York, United States
Change From Baseline in Numeric Rating Scale (NRS)
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.
Time frame: Baseline, Days 2, 6, 14, and 28
Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score
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.
Time frame: Baseline and Week 4
Change From Baseline in C-reactive Protein (CRP)
CRP (measured in mg/dL) is an inflammatory marker. A higher value is correlated with more severe disease.
Time frame: Baseline and Week 4
Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size
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.
Time frame: Baseline and Week 4
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)
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".
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Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
Time frame: Baseline, Days 2, 6, 14, and 28
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
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.
Time frame: Baseline
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
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.
Time frame: Day 2
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
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.
Time frame: Day 6
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
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.
Time frame: Day 14
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
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.
Time frame: Day 28
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
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.
Time frame: Baseline and Week 4
Baseline Patient Satisfaction Likert Scale
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.
Time frame: Baseline
Change From Baseline in Patient Satisfaction Likert Scale
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.
Time frame: Days 2, 6, 14, and 28
Change From Baseline in Interleukin-6 (IL-6)
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.
Time frame: Baseline and Week 4