NCT04582669|TerminatedPhase 4ResultsFDA Drug
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This study was administratively closed.
Sponsor study identifier
interventional
11
1 country
1
Study Start
January 24, 2022
Actual (reported)Primary Completion
October 12, 2022
Actual (reported)Study Completion
October 12, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 12, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2020
Actual (reported)October 9, 2020
Actual (reported)January 24, 2022
Actual (reported)October 12, 2022
Actual (reported)October 12, 2022
Actual (reported)November 13, 2023
Actual (reported)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
Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score
Baseline and Week 4
Change From Baseline in C-reactive Protein (CRP)
Baseline and Week 4
Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size
Baseline and Week 4
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)
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.
Baseline
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.
Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
Steven Cohen
The Bronx, New York, 10467, United States
Steven R Cohen, MD, MPH
Albert Einstein College of Medicine Montefiore Medical Center
11 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2020
First Posted
October 9, 2020
Study Start
January 24, 2022
Actual (reported)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.
Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 12, 2022
Actual (reported)Study Completion
October 12, 2022
Actual (reported)Last Updated
November 13, 2023
Results First Posted
November 13, 2023
Record last verified: 2023-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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