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Clinical trial

Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

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Last updated:11th Aug 2021
Status: Not yet recruiting
Identifier: NCT04582669
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

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.

Study Type: Interventional (Clinical Trial)
Estimated 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
Estimated Study Start Date: October 2021
Estimated Primary Completion Date: October 2022
Estimated Study Completion Date: October 2022

- Placebo Comparator: Sodium Chloride 0.9%
- Active Comparator: Intralesional Triamcinolone 10 mg/mL
- Experimental: Intralesional Triamcinolone 20 mg/mL
- Experimental: Intralesional Triamcinolone 40 mg/mL

Category Value
Study type(s) Interventional
Estimated enrolment 200
Estimated Study start date 01 October 2021
Estimated Study Completion Date 01 October 2022

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