Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Intralesional Triamcinolone 10 mg/mL
* Drug: Intralesional Triamcinolone 20 mg/mL
* Drug: Intralesional Triamcinolone 40 mg/mL
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sodium Chloride 0.9%<br>Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL. | Drug: Placebo<br>* Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.<br>|
| Active Comparator: Intralesional Triamcinolone 10 mg/mL<br>Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. | Drug: Intralesional Triamcinolone 10 mg/mL<br>* Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.<br>|
| Experimental: Intralesional Triamcinolone 20 mg/mL<br>Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. | Drug: Intralesional Triamcinolone 20 mg/mL<br>* Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.<br>|
| Experimental: Intralesional Triamcinolone 40 mg/mL<br>Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. | Drug: Intralesional Triamcinolone 40 mg/mL<br>* Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Days 2, 6, 14, and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 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. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules. | 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 Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 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. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules. | 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 Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 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. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules. | 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 Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 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. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules. | 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 Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 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. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules. | 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. | 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. | 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. | 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. | Baseline and Week 4 |