Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

NCT ID: NCT04582669

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2022-10-12

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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sodium Chloride 0.9%

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.

Intralesional Triamcinolone 10 mg/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.

Group Type: ACTIVE_COMPARATOR

Intralesional Triamcinolone 10 mg/mL

Intervention Type: DRUG

Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.

Intralesional Triamcinolone 20 mg/mL

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.

Group Type: EXPERIMENTAL

Intralesional Triamcinolone 20 mg/mL

Intervention Type: DRUG

Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.

Intralesional Triamcinolone 40 mg/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.

Group Type: EXPERIMENTAL

Intralesional Triamcinolone 40 mg/mL

Intervention Type: DRUG

Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Interventions

Intralesional Triamcinolone 10 mg/mL

Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.

Intervention Type: DRUG

Intralesional Triamcinolone 20 mg/mL

Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.

Intervention Type: DRUG

Intralesional Triamcinolone 40 mg/mL

Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Intervention Type: DRUG

Placebo

Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Cohen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine Montefiore Medical Center

Locations

Steven Cohen

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-12227

Identifier Type: -

Identifier Source: org_study_id