A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.

NCT02781818 | Completed Results

• 1 other identifier: 16-0773
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To evaluate the effectiveness of intralesional triamcinolone for the treatment of hidradenitis suppurativa (HS) Participants: Patients diagnosed with Hidradenitis Suppurativa that have active inflammatory HS lesions. Up to 60 lesions will be treated. Between 20 and 60 patients will be enrolled dependent on the number of lesions they have treated. (up to 3 per patient) Procedures (methods): Injection of triamcinolone or placebo into active lesions of hidradenitis suppurativa

Conditions

Hidradenitis Suppurativa

Keywords

hidradenitis; intralesional; triamcinolone

Outcome Measures

Primary Outcomes (1)

• Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.

  Mean number of days that patient reports it takes for a lesion to resolve. This is defined as a return of the skin to baseline in the treated area and an absence of pain.

  1-14 days

Secondary Outcomes (2)

• Change in Pain From Baseline to Day 5

  Baseline, Day 5

• Patient Rating of Impression of Treatment at Day 14

  14 days

Study Arms (3)

Triamcinolone Acetonide 10mg/mL

EXPERIMENTAL

Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution.

Drug: Triamcinolone Acetonide 10mg/mL

Triamcinolone Acetonide 40mg/mL

EXPERIMENTAL

Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.

Drug: Triamcinolone Acetonide 40mg/mL

Normal Saline Placebo

PLACEBO COMPARATOR

Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of sterile normal saline solution.

Drug: Normal Saline

Interventions

Triamcinolone Acetonide 10mg/mL DRUG

Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use.

Also known as: Kenalog®-10

Triamcinolone Acetonide 10mg/mL

Triamcinolone Acetonide 40mg/mL DRUG

Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use.

Also known as: Kenalog®-40

Triamcinolone Acetonide 40mg/mL

Normal Saline DRUG

Normal saline 0.1 mL will be administered intralesionally at the selected site.

Also known as: Placebo

Normal Saline Placebo

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females \> or = 16 years of age
• Diagnosis or history of clinical features consistent with hidradenitis suppurativa for \>1 year
• Patient must have an inflammatory lesion at the time of treatment. This can be an inflammatory nodule defined by a tender, palpable subcutaneous nodule, or an abscess defined as as fluctuant, painful, subcutaneous nodule. Lesions greater than 2 centimeters in size will not be excluded. Inflammatory nodules or abscesses can be treated if they are associated with a sinus tract, which is a chronic HS lesion defined by tunneled lesion with multiple openings to the surface of the skin. Sinus tracts without associated nodules or abscesses will not be treatment targets.
• Patient must be off of antibiotics or on a stable course of oral antibiotics for \>4 weeks prior to the baseline visit. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/- rifampin.
• Must be able to provide adequate informed consent for themselves

You may not qualify if:

• Any patient with signs of active infection at the time of screening that is not related to their hidradenitis suppurativa
• Patients who have been on non-permitted antibiotics in the 4 weeks prior to baseline. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/- rifampin.
• Patients who have had surgical intervention of the treated body region (i.e., right axilla) beyond incision and drainage procedures in the last 8 weeks or with open surgical wounds in the treatment region.
• Patients who have been started on immunomodulatory or biologic treatment (i.e., adalimumab, infliximab) in the past 4 weeks
• Patients on non-stable doses of opiate analgesics for the last 14 days prior to screening
• Patients with history of hypersensitivity reactions to triamcinolone
• Ongoing health or physical exam concerns which the investigator feels may put the patient at significant risk

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Department of Dermatology

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (1)

• Fajgenbaum K, Crouse L, Dong L, Zeng D, Sayed C. Intralesional Triamcinolone May Not Be Beneficial for Treating Acute Hidradenitis Suppurativa Lesions: A Double-Blind, Randomized, Placebo-Controlled Trial. Dermatol Surg. 2020 May;46(5):685-689. doi: 10.1097/DSS.0000000000002112.

  PMID: 31490300 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis

Interventions

Triamcinolone Acetonide; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Christopher Sayed
• Organization: UNC Dermatology

christopher_sayed@email.unc.edu

984-974-3900

Study Officials

• Christopher J Sayed, MD

  UNC Dermatology

  PRINCIPAL INVESTIGATOR

• Erika Hanami, CCRC

  Project Manager

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 24, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 23, 2018
• Results First Posted: March 9, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)