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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Interventions Drug: Triamcinolone Acetonide 10mg/mL
Drug: Triamcinolone Acetonide 40mg/mL
Drug: Normal Saline
Enrollment 32
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).
Arm/Group Title Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo
Hide Arm/Group Description Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution. Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution. Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1 mL of sterile normal saline solution.
Period Title: Overall Study
Number of participants Number of units (Lesions) Number of participants Number of units (Lesions) Number of participants Number of units (Lesions)
Started 20 24 18 22 17 21
Completed 16 18 16 20 16 20
Not Completed 4 6 2 2 1 1
Reason Not Completed
Lost to Follow-up             4                         2                         1            
Arm/Group Title Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo Total
Hide Arm/Group Description Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution. Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution. Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution. Total of all reporting groups
Overall Number of Baseline Participants 16 16 16 48
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
18 20 20 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 16 participants 48 participants
<=18 years
0
   0.0%
1
   6.3%
1
   6.3%
2
   4.2%
Between 18 and 65 years
15
  93.8%
15
  93.8%
14
  87.5%
44
  91.7%
>=65 years
1
   6.3%
0
   0.0%
1
   6.3%
2
   4.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 16 participants 48 participants
Female
12
  75.0%
14
  87.5%
15
  93.8%
41
  85.4%
Male
4
  25.0%
2
  12.5%
1
   6.3%
7
  14.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 16 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  56.3%
6
  37.5%
8
  50.0%
23
  47.9%
White
7
  43.8%
10
  62.5%
8
  50.0%
25
  52.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 16 participants 48 participants
16
 100.0%
16
 100.0%
16
 100.0%
48
 100.0%
1.Primary Outcome
Title Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo
Hide Arm/Group Description:
Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
Overall Number of Participants Analyzed 16 16 16
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
18 20 20
Mean (95% Confidence Interval)
Unit of Measure: Days
10.8
(8.2 to 13.4)
10.9
(8.8 to 12.9)
9.35
(6.9 to 11.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triamcinolone Acetonide 10mg/mL, Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Triamcinolone Acetonide 40mg/mL, Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change in Pain From Baseline to Day 5
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo
Hide Arm/Group Description:
Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
Overall Number of Participants Analyzed 16 16 16
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
18 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2
(.65 to 3.3)
2.3
(1.1 to 3.5)
2.6
(1.4 to 3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triamcinolone Acetonide 10mg/mL, Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .65
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Triamcinolone Acetonide 40mg/mL, Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Patient Rating of Impression of Treatment at Day 14
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo
Hide Arm/Group Description:
Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.
Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.
Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
Overall Number of Participants Analyzed 16 16 16
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
18 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.5
(1.8 to 4.3)
2.5
(1.9 to 4.4)
2.4
(1.7 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Triamcinolone Acetonide 10mg/mL, Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Triamcinolone Acetonide 40mg/mL, Normal Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 14 days
Adverse Event Reporting Description Adverse event collections was done by phone on or about day 14 following the study intervention.
 
Arm/Group Title Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/18 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/18 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Triamcinolone Acetonide 10mg/mL Triamcinolone Acetonide 40mg/mL Normal Saline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/18 (0.00%)   0/17 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Christopher Sayed
Organization: UNC Dermatology
Phone: 984-974-3900
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02781818     History of Changes
Other Study ID Numbers: 16-0773
First Submitted: May 20, 2016
First Posted: May 24, 2016
Results First Submitted: February 9, 2018
Results First Posted: March 9, 2018
Last Update Posted: May 23, 2018