Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

Montefiore Medicine Academic Health System

Status and phase: Terminated; Phase 4

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Intralesional Triamcinolone 10 mg/mL; Drug: Placebo; Drug: Intralesional Triamcinolone 40 mg/mL; Drug: Intralesional Triamcinolone 20 mg/mL

Study type: Interventional

Funder types: Other

Identifiers

NCT04582669

2020-12227

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

11 participants in 4 patient groups, including a placebo group

Sodium Chloride 0.9%

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Intralesional Triamcinolone 10 mg/mL

Active Comparator group

Description:

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.

Treatment:

Drug: Intralesional Triamcinolone 10 mg/mL

Intralesional Triamcinolone 20 mg/mL

Experimental group

Description:

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.

Treatment:

Drug: Intralesional Triamcinolone 20 mg/mL

Intralesional Triamcinolone 40 mg/mL

Experimental group

Description:

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.

Treatment:

Drug: Intralesional Triamcinolone 40 mg/mL