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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

Purpose: To evaluate the effectiveness of intralesional triamcinolone for the treatment of hidradenitis suppurativa

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 Summary:

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.

Same as current

Current Secondary Outcome:

  • Change in pain from baseline to day 5 [ Time Frame: 5 days ]
    Patients will rate pain on a scale of 1-10 (1 being no pain, 10 being the worst possible pain) at the baseline visit and on days 1, 2, 3, 5, 7, 10, and 14. A secondary outcome will compare reduction in pain on day 5 in the combined treatment groups compared to the placebo group, and between the two treatment arms.
  • Patient rating of impression of treatment at day 14 [ Time Frame: 14 days ]

    Patients will rate their impression of the treatment for each site as follows:

    0. Made it worse;

    1. Not helpful;
    2. A little bit helpful;
    3. Moderately helpful;
    4. Very helpful

    Comparison of rating of impression of treatment between the combined treatment groups and placebo will be performed. Similar comparison will be performed between the triamcinolone 10mg/ml and triamcinolone 40mg/ml treatment arms.



Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: May 20, 2016
Date Started: June 2016
Date Completion: July 2017
Last Updated: May 2, 2017
Last Verified: May 2017