NCT02781818

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

A Randomized, Controlled, Double-blind Study to Evaluate the Efficacy of Intralesional Triamcinolone in the Treatment of Hidradenitis Suppurativa.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 16 Years – 99 Years
• Healthy volunteers: Accepted

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

Detailed description

This will be a randomized, double-blind, placebo-controlled trial of two concentrations of intralesional triamcinolone, triamcinolone 40mg/mL and triamcinolone 10mg/mL, with normal saline as a placebo control. For subjects with lesions deemed appropriate for the study, between one and three treatment sites will be marked with sequential lettering with a skin marker and documented by body location. Baseline pain level of each lesion will be recorded. At that time each lesion will be randomized in a 1:1:1 fashion to be treated with intralesional triamcinolone 10mg/mL, triamcinolone 40mg/mL, or normal saline placebo. Following treatment, subjects will be given a paper questionnaire that will ask them to rate their level of pain on a 1-10 scale for each lesion, and whether they believe the target lesion has resolved on days 1, 2, 3, 5, 7, 10, and 14. On day 14 they will also rate how helpful they think the treatment is on a scale of 0-4. These will be patient-reported outcomes only without any physician assessment as this is felt to be a more clinically relevant outcome. Aim 1. Characterize and compare the 3 regimens in terms of days to resolution of treated lesion. Hypotheses for Aim 1: Days to resolution of treated lesions will be fewer in the treatment groups compared to normal saline placebo, and will be fewer with triamcinolone 40mg/mL compared to triamcinolone 10mg/mL. Aim 2. Characterize and compare the 3 regimens in terms of pain level on day 5. Hypotheses for Aim 2: Rating of pain will be less in the treatment groups compared to normal saline placebo, and will be less with triamcinolone 40mg/mL compared to triamcinolone 10mg/mL at day 5. Aim 3. Characterize and compare the 3 regimens in terms of patient rating of the "benefit of the treatment Hypotheses for Aim 1: Patient rating will be more favorable the treatment groups compared to normal saline placebo, and will be more favorable with triamcinolone 40mg/mL compared to triamcinolone 10mg/mL.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide 10mg/mL	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.
DRUG	Triamcinolone Acetonide 40mg/mL	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.
DRUG	Normal Saline	Normal saline 0.1 mL will be administered intralesionally at the selected site.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2016-05-24
• Last updated: 2018-05-23
• Results posted: 2018-03-09

Locations

1 site across 1 country: United States