Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

  • STATUS
    Recruiting
  • End date
    Oct 25, 2022
  • participants needed
    200
  • sponsor
    Montefiore Medical Center
Updated on 25 March 2022
abscess
triamcinolone
Accepts healthy volunteers

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.

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.

Details
Condition Hidradenitis Suppurativa
Treatment Placebo, Intralesional Triamcinolone 10 mg/ml, Intralesional Triamcinolone 20 mg/mL, Intralesional Triamcinolone 40 mg/mL
Clinical Study IdentifierNCT04582669
SponsorMontefiore Medical Center
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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