Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide 10mg/mL | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 5 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher J Sayed, MD | UNC Dermatology | Principal Investigator |
| Erika Hanami, CCRC | Project Manager | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Department of Dermatology | Chapel Hill | North Carolina | 27516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31490300 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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
| ID | Title | Description |
|---|---|---|
| FG000 | Triamcinolone Acetonide 10mg/mL | Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution. |
| FG001 | Triamcinolone Acetonide 40mg/mL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2017 | Feb 2, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Triamcinolone Acetonide 40mg/mL | Drug | 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 | Drug | Normal saline 0.1 mL will be administered intralesionally at the selected site. |
|
|
| 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;
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. | 14 days |
Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.
| FG002 | Normal Saline Placebo | Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1 mL of sterile normal saline solution. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| ID | Title | Description |
|---|---|---|
| BG000 | Triamcinolone Acetonide 10mg/mL | Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution. |
| BG001 | Triamcinolone Acetonide 40mg/mL | Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution. |
| BG002 | Normal Saline Placebo | Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| lesions |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | Days | 1-14 days | Lesions | Lesions |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Day 5 | Lesions | Lesions |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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;
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. | Posted | Mean | 95% Confidence Interval | units on a scale | 14 days | Lesions | Lesions |
|
14 days
Adverse event collections was done by phone on or about day 14 following the study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Triamcinolone Acetonide 10mg/mL | Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution. 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Triamcinolone Acetonide 40mg/mL | Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution. 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. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Normal Saline Placebo | Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of sterile normal saline solution. Normal Saline: Normal saline 0.1mL will be administered intralesionally at the selected site. | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Sayed | UNC Dermatology | 984-974-3900 | christopher_sayed@email.unc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2017 | Feb 2, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D016575 | Hidradenitis |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
| Participants |
|
| Lesions |
|
|
|
| Units | Counts |
|---|
| Participants |
|
| Lesions |
|
|
|