NCT04582669

Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Intralesional Triamcinolone 10 mg/mL	Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
DRUG	Intralesional Triamcinolone 20 mg/mL	Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
DRUG	Intralesional Triamcinolone 40 mg/mL	Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
DRUG	Placebo	Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.

Timeline

• Start date: 2022-01-24
• Primary completion: 2022-10-12
• Completion: 2022-10-12
• First posted: 2020-10-09
• Last updated: 2023-11-13
• Results posted: 2023-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study