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Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intralesional Triamcinolone 10 mg/mL
Intralesional Triamcinolone 20 mg/mL
Intralesional Triamcinolone 40 mg/mL
Placebo
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Steven Cohen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Arm Label

Sodium Chloride 0.9%

Intralesional Triamcinolone 10 mg/mL

Intralesional Triamcinolone 20 mg/mL

Intralesional Triamcinolone 40 mg/mL

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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".
Proportion 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 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.
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.
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.
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.

Full Information

First Posted
September 29, 2020
Last Updated
May 17, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04582669
Brief Title
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Official Title
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
This study was administratively closed.
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
October 12, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Chloride 0.9%
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intralesional Triamcinolone 10 mg/mL
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intralesional Triamcinolone 20 mg/mL
Arm Type
Experimental
Arm Description
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.
Arm Title
Intralesional Triamcinolone 40 mg/mL
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intralesional Triamcinolone 10 mg/mL
Intervention Description
Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
Intervention Type
Drug
Intervention Name(s)
Intralesional Triamcinolone 20 mg/mL
Intervention Description
Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
Intervention Type
Drug
Intervention Name(s)
Intralesional Triamcinolone 40 mg/mL
Intervention Description
Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
Primary Outcome Measure Information:
Title
Change from baseline in Numeric Rating Scale (NRS)
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.
Time Frame
Baseline, Days 2, 6, 14, and 28
Secondary Outcome Measure Information:
Title
Change from baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) score
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.
Time Frame
Baseline and Week 4
Title
Change from baseline in C-reactive protein (CRP)
Description
CRP (measured in mg/dL) is an inflammatory marker. A higher value is correlated with more severe disease.
Time Frame
Baseline and Week 4
Title
Change from baseline in Hidradenitis Suppurativa (HS) lesion size
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.
Time Frame
Baseline and Week 4
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)
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".
Time Frame
Baseline, Days 2, 6, 14, and 28
Title
Proportion of subjects reporting thinning and/or atrophy of the skin, acneiform lesion(s), capillary dilation(s), and dyschromia when compared to baseline.
Description
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.
Time Frame
Baseline, Days 2, 6, 14, and 28.
Title
Baseline Patient Satisfaction Likert scale
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.
Time Frame
Baseline
Title
Change from baseline in Patient Satisfaction Likert scale
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.
Time Frame
Baseline, Days 2, 6, 14, and 28
Title
Change from baseline in Interleukin-6 (IL-6)
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.
Time Frame
Baseline and Week 4
Title
Change from baseline in Erythrocyte sedimentation rate (ESR)
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.
Time Frame
Baseline and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Cohen, MD, MPH
Organizational Affiliation
Albert Einstein College of Medicine Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steven Cohen
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

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Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

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