Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

NCT04582669 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2020-12227
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Numeric Rating Scale (NRS)

  Numeric Rating Scale is a pain scale scored with whole integers from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable". Higher score indicates worse pain.

  Baseline, Days 2, 6, 14, and 28

Secondary Outcomes (13)

• Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score

  Baseline and Week 4

• Change From Baseline in C-reactive Protein (CRP)

  Baseline and Week 4

• Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size

  Baseline and Week 4

• Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)

  Baseline, Days 2, 6, 14, and 28

• Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.

  Baseline

Study Arms (4)

Sodium Chloride 0.9%

PLACEBO COMPARATOR

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.

Drug: Placebo

Intralesional Triamcinolone 10 mg/mL

ACTIVE COMPARATOR

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.

Drug: Intralesional Triamcinolone 10 mg/mL

Intralesional Triamcinolone 20 mg/mL

EXPERIMENTAL

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.

Drug: Intralesional Triamcinolone 20 mg/mL

Intralesional Triamcinolone 40 mg/mL

EXPERIMENTAL

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.

Drug: Intralesional Triamcinolone 40 mg/mL

Interventions

Intralesional Triamcinolone 10 mg/mL DRUG

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

Intralesional Triamcinolone 10 mg/mL

Intralesional Triamcinolone 20 mg/mL DRUG

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

Intralesional Triamcinolone 20 mg/mL

Intralesional Triamcinolone 40 mg/mL DRUG

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

Intralesional Triamcinolone 40 mg/mL

Placebo DRUG

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

Sodium Chloride 0.9%

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Steven Cohen

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Haley Heibel, MD
• Organization: Montefiore Medical Center

hheibel@montefiore.org

(718) 920-8352

Study Officials

• Steven R Cohen, MD, MPH

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 9, 2020
• Study Start: January 24, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Locations

US (1)