Hidradenitis SuppurativaNCT02781818
A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.
A study testing Triamcinolone Acetonide 10mg/mL, Triamcinolone Acetonide 40mg/mL and Normal Saline in people with Hidradenitis Suppurativa, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Triamcinolone Acetonide 10mg/mL, Triamcinolone Acetonide 40mg/mL and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jul 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Department of Dermatology
Chapel Hill, North Carolina, 27516
About this study
Official title: A Randomized, Controlled, Double-blind Study to Evaluate the Efficacy of Intralesional Triamcinolone in the Treatment of Hidradenitis Suppurativa.
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
Read the 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
- Being tested
- Triamcinolone Acetonide 10mg/mL, Triamcinolone Acetonide 40mg/mL, Normal Saline
- Keywords
- hidradenitis, intralesional, triamcinolone
- Medical subject headings
- Hidradenitis Suppurativa, Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide 10mg/mLDrug
Also called Kenalog®-10
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 40mg/mLDrug
Also called Kenalog®-40
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 SalineDrug
Also called Placebo
Normal saline 0.1 mL will be administered intralesionally at the selected site.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone Acetonide 10mg/mL | Experimental | Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution. Receives: Drug: Triamcinolone Acetonide 10mg/mL |
| Triamcinolone Acetonide 40mg/mL | Experimental | Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution. Receives: Drug: Triamcinolone Acetonide 40mg/mL |
| Normal Saline Placebo | Placebo comparator | Each lesion randomized to this group will receive a single intralesional treatment with 0.1 mL of sterile normal saline solution. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-14 days
Secondary outcomes (2)
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.
Measured: Baseline, Day 5
Patient Rating of Impression of Treatment at Day 14
Patients will rate their impression of the treatment for each site as follows:
- 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher J Sayed, MD, Principal investigator, UNC DermatologyErika Hanami, CCRC, Study director, Project Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781818
- Sponsor's protocol ID
- 16-0773
- Status last verified
- Feb 2018
- First submitted
- 20 May 2016
- Last updated
- 23 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31490300