Hidradenitis Suppurativa
Conditions
Keywords
hidradenitis, intralesional, triamcinolone
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.
Interventions
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.
DRUGNormal Saline
Normal saline 0.1 mL will be administered intralesionally at the selected site.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain From Baseline to Day 5 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Patients presenting to an academic dermatology department in a subspecialty hidradenitis suppurativa clinic were enrolled during clinic visits between 6/20/2016 and 5/17/2017
Pre-assignment details
The design allows for individual subjects to have multiple lesions randomized to distinct treatment arms, which means a single subject could be included as participants in multiple arms. This results in the total participant number calculated by adding participants in each arm to be higher (55) than the number of subjects enrolled (32).
Participants by arm
| Arm | Count |
|---|---|
| Triamcinolone Acetonide 10mg/mL Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution. | 16 |
| Triamcinolone Acetonide 10mg/mL Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution. | 18 |
| Triamcinolone Acetonide 40mg/mL Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution. | 16 |
| Triamcinolone Acetonide 40mg/mL Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution. | 20 |
| Normal Saline Placebo Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution. | 16 |
| Normal Saline Placebo Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution. | 20 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Triamcinolone Acetonide 10mg/mL | Triamcinolone Acetonide 40mg/mL | Normal Saline Placebo |
|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 15 Participants | 15 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 9 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 7 Participants | 10 Participants | 8 Participants |
| Region of Enrollment United States | 48 Participants | 16 Participants | 16 Participants | 16 Participants |
| Sex: Female, Male Female | 41 Participants | 12 Participants | 14 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 0 / 20 | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 | 0 / 17 |
Outcome results
Primary
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.
Time frame: 1-14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Triamcinolone Acetonide 10mg/mL | Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm. | 10.8 Days |
| Triamcinolone Acetonide 40mg/mL | Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm. | 10.9 Days |
| Normal Saline Placebo | Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm. | 9.35 Days |
p-value: 0.77Mixed Models Analysis
p-value: 0.46Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Day 5
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Triamcinolone Acetonide 10mg/mL | Change in Pain From Baseline to Day 5 | 2 units on a scale |
| Triamcinolone Acetonide 40mg/mL | Change in Pain From Baseline to Day 5 | 2.3 units on a scale |
| Normal Saline Placebo | Change in Pain From Baseline to Day 5 | 2.6 units on a scale |
p-value: 0.65Mixed Models Analysis
p-value: 0.98Mixed Models Analysis
Secondary
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; 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.
Time frame: 14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Triamcinolone Acetonide 10mg/mL | Patient Rating of Impression of Treatment at Day 14 | 2.5 units on a scale |
| Triamcinolone Acetonide 40mg/mL | Patient Rating of Impression of Treatment at Day 14 | 2.5 units on a scale |
| Normal Saline Placebo | Patient Rating of Impression of Treatment at Day 14 | 2.4 units on a scale |
p-value: 0.5Mixed Models Analysis
p-value: 0.7Mixed Models Analysis