Clinical trial NCT04582669: Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Official title: Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hidradenitis Suppurativa
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 11
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Numeric Rating Scale (NRS)
timeFrame: Baseline, Days 2, 6, 14, and 28
Secondary outcomes:
measure: Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score
timeFrame: Baseline and Week 4
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: Baseline and Week 4
measure: Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size
timeFrame: Baseline and Week 4
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, Days 2, 6, 14, and 28
measure: Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
timeFrame: Baseline
measure: Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
timeFrame: Day 2
measure: Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
timeFrame: Day 6
measure: Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
timeFrame: Day 14
measure: Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
timeFrame: Day 28
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline and Week 4
measure: Baseline Patient Satisfaction Likert Scale
timeFrame: Baseline
measure: Change From Baseline in Patient Satisfaction Likert Scale
timeFrame: Days 2, 6, 14, and 28
measure: Change From Baseline in Interleukin-6 (IL-6)
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Steven Cohen
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine Montefiore Medical Center
name: Steven R Cohen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: