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

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ClinicalTrials.gov Identifier: NCT02781818
Recruitment Status : Completed
First Posted : May 24, 2016
Results First Posted : March 9, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE May 20, 2016
First Posted Date  ICMJE May 24, 2016
Results First Submitted Date  ICMJE February 9, 2018
Results First Posted Date  ICMJE March 9, 2018
Last Update Posted Date May 23, 2018
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm. [ Time Frame: 1-14 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm. [ Time Frame: 1-14 days ]
Change History Complete list of historical versions of study NCT02781818 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • Change in Pain From Baseline to Day 5 [ Time Frame: Baseline, Day 5 ]
    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 day 5. 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 Measures  ICMJE
 (submitted: May 23, 2016)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.
Official Title  ICMJE 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 (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • 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.
    Other Name: Kenalog®-10
  • 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.
    Other Name: Kenalog®-40
  • Drug: Normal Saline
    Normal saline 0.1 mL will be administered intralesionally at the selected site.
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Triamcinolone Acetonide 10mg/mL
    Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution.
    Intervention: Drug: Triamcinolone Acetonide 10mg/mL
  • Experimental: Triamcinolone Acetonide 40mg/mL
    Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.
    Intervention: Drug: Triamcinolone Acetonide 40mg/mL
  • Placebo Comparator: Normal Saline Placebo
    Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of sterile normal saline solution.
    Intervention: Drug: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2016)
50
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and females > or = 16 years of age
  2. Diagnosis or history of clinical features consistent with hidradenitis suppurativa for >1 year
  3. 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.
  4. 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.
  5. Must be able to provide adequate informed consent for themselves

Exclusion Criteria:

  1. Any patient with signs of active infection at the time of screening that is not related to their hidradenitis suppurativa
  2. 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.
  3. 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.
  4. Patients who have been started on immunomodulatory or biologic treatment (i.e., adalimumab, infliximab) in the past 4 weeks
  5. Patients on non-stable doses of opiate analgesics for the last 14 days prior to screening
  6. Patients with history of hypersensitivity reactions to triamcinolone
  7. Ongoing health or physical exam concerns which the investigator feels may put the patient at significant risk
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02781818
Other Study ID Numbers  ICMJE 16-0773
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher J Sayed, MD UNC Dermatology
Study Director: Erika Hanami, CCRC Project Manager
PRS Account University of North Carolina, Chapel Hill
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP