Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

Sponsor

Montefiore Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04582669

Collaborator

(none)

200

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

24.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa	Drug: Intralesional Triamcinolone 10 mg/mL Drug: Intralesional Triamcinolone 20 mg/mL Drug: Intralesional Triamcinolone 40 mg/mL Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

Actual Study Start Date :

Jan 24, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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.	Drug: Placebo 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.	Drug: Intralesional Triamcinolone 10 mg/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.	Drug: Intralesional Triamcinolone 20 mg/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.	Drug: Intralesional Triamcinolone 40 mg/mL Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Outcome Measures

Primary Outcome Measures

Change from baseline in Numeric Rating Scale (NRS) [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.

Secondary Outcome Measures

Change from baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) score [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.
Change from baseline in C-reactive protein (CRP) [Baseline and Week 4]
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 [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.
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) [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".
Proportion of subjects reporting thinning and/or atrophy of the skin, acneiform lesion(s), capillary dilation(s), and dyschromia when compared to baseline. [Baseline, Days 2, 6, 14, and 28.]
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 [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.
Change from baseline in Patient Satisfaction Likert scale [Baseline, 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.
Change from baseline in Interleukin-6 (IL-6) [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.
Change from baseline in Erythrocyte sedimentation rate (ESR) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.