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Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

NCT04582669 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-11-13

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Steven R Cohen, MD, MPH · Albert Einstein College of Medicine Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2022-10-12
Completion
2022-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04582669 on ClinicalTrials.gov