A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional

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.
    

Intervention name(s): Triamcinolone Acetonide 10mg/mL; Triamcinolone Acetonide 40mg/mL; Normal Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; Normal saline 0.1 mL will be administered intralesionally at the selected site.
Other intervention name(s): Kenalog®-10; Kenalog®-40; Placebo
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hidradenitis; intralesional; triamcinolone