- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04582669
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10467
- Steven Cohen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sodium Chloride 0.9%
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.
|
Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Active Comparator: Intralesional Triamcinolone 10 mg/mL
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.
|
Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Experimental: Intralesional Triamcinolone 20 mg/mL
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.
|
Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Experimental: Intralesional Triamcinolone 40 mg/mL
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.
|
Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Numeric Rating Scale (NRS)
Time Frame: Baseline, Days 2, 6, 14, and 28
|
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
Time Frame: Baseline and Week 4
|
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)
Time Frame: Baseline and Week 4
|
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
Time Frame: Baseline and Week 4
|
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)
Time Frame: Baseline, Days 2, 6, 14, and 28
|
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.
Time Frame: Baseline
|
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
|
Baseline
|
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Time Frame: Day 2
|
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
|
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.
Time Frame: Day 6
|
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
|
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.
Time Frame: Day 14
|
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
|
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.
Time Frame: Day 28
|
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
|
Day 28
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline and Week 4
|
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
Time Frame: Baseline
|
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
Time Frame: Days 2, 6, 14, and 28
|
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)
Time Frame: Baseline and Week 4
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven R Cohen, MD, MPH, Albert Einstein College of Medicine Montefiore Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Sweat Gland Diseases
- Skin Diseases
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Suppuration
- Skin Diseases, Bacterial
- Hidradenitis Suppurativa
- Hidradenitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- 2020-12227
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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