Back to resultsA Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone Acetonide 10mg/mL
Triamcinolone Acetonide 40mg/mL
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring hidradenitis, intralesional, triamcinolone
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of North Carolina Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Triamcinolone Acetonide 10mg/mL
Triamcinolone Acetonide 40mg/mL
Normal Saline Placebo
Arm Description
Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution.
Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.
Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of sterile normal saline solution.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Pain From Baseline to 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
Patients will rate their impression of the treatment for each site as follows:
0. Made it worse;
Not helpful;
A little bit helpful;
Moderately helpful;
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.
Full Information
NCT ID
NCT02781818
First Posted
May 20, 2016
Last Updated
April 24, 2018
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT02781818
Brief Title
A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.
Official Title
A Randomized, Controlled, Double-blind Study to Evaluate the Efficacy of Intralesional Triamcinolone in the Treatment of Hidradenitis Suppurativa.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
hidradenitis, intralesional, triamcinolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triamcinolone Acetonide 10mg/mL
Arm Type
Experimental
Arm Description
Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution.
Arm Title
Triamcinolone Acetonide 40mg/mL
Arm Type
Experimental
Arm Description
Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.
Arm Title
Normal Saline Placebo
Arm Type
Placebo Comparator
Arm Description
Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of sterile normal saline solution.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 10mg/mL
Other Intervention Name(s)
Kenalog®-10
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide 40mg/mL
Other Intervention Name(s)
Kenalog®-40
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Placebo
Intervention Description
Normal saline 0.1 mL will be administered intralesionally at the selected site.
Primary Outcome Measure Information:
Title
Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.
Description
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.
Time Frame
1-14 days
Secondary Outcome Measure Information:
Title
Change in Pain From Baseline to Day 5
Description
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.
Time Frame
Baseline, Day 5
Title
Patient Rating of Impression of Treatment at Day 14
Description
Patients will rate their impression of the treatment for each site as follows:
0. Made it worse;
Not helpful;
A little bit helpful;
Moderately helpful;
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.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Sayed, MD
Organizational Affiliation
UNC Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erika Hanami, CCRC
Organizational Affiliation
Project Manager
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina Department of Dermatology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31490300
Citation
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.
Results Reference
derived
Learn more about this trial
A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.
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