Trial Outcomes & Findings for A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa. (NCT NCT02781818)

Last Updated: 2018-05-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

1-14 days

Results posted on

2018-05-23

Participant Flow

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

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).

Unit of analysis: Lesions

Participant milestones

Participant milestones
Measure	Triamcinolone Acetonide 10mg/mL Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution.	Triamcinolone Acetonide 40mg/mL Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.	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.
Overall Study STARTED	20 24	18 22	17 21
Overall Study COMPLETED	16 18	16 20	16 20
Overall Study NOT COMPLETED	4 6	2 2	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Triamcinolone Acetonide 10mg/mL Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 10mg/mL solution.	Triamcinolone Acetonide 40mg/mL Each lesion randomized to this group received a single intralesional treatment with 0.1 mL of triamcinolone 40mg/mL solution.	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.
Overall Study Lost to Follow-up	4	2	1

Baseline Characteristics

A Randomized Controlled Trial Evaluating the Efficacy of Intralesional Triamcinolone in Hidradenitis Suppurativa.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triamcinolone Acetonide 10mg/mL n=18 lesions Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.	Triamcinolone Acetonide 40mg/mL n=20 lesions Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.	Normal Saline Placebo n=20 lesions Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.	Total n=58 lesions Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	44 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	16 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	48 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide 10mg/mL n=18 Lesions Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.	Triamcinolone Acetonide 40mg/mL n=20 Lesions Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.	Normal Saline Placebo n=20 Lesions Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.	10.8 Days Interval 8.2 to 13.4	10.9 Days Interval 8.8 to 12.9	9.35 Days Interval 6.9 to 11.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide 10mg/mL n=18 Lesions Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.	Triamcinolone Acetonide 40mg/mL n=20 Lesions Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.	Normal Saline Placebo n=20 Lesions Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
Change in Pain From Baseline to Day 5	2 units on a scale Interval 0.65 to 3.3	2.3 units on a scale Interval 1.1 to 3.5	2.6 units on a scale Interval 1.4 to 3.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide 10mg/mL n=18 Lesions Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.	Triamcinolone Acetonide 40mg/mL n=20 Lesions Each lesion randomized to this group received a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.	Normal Saline Placebo n=20 Lesions Each lesion randomized to this group received a single intralesional treatment with non-bacteriostatic 0.1mL of sterile normal saline solution.
Patient Rating of Impression of Treatment at Day 14	2.5 units on a scale Interval 1.8 to 4.3	2.5 units on a scale Interval 1.9 to 4.4	2.4 units on a scale Interval 1.7 to 4.1

Adverse Events

Triamcinolone Acetonide 10mg/mL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Triamcinolone Acetonide 40mg/mL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christopher Sayed

UNC Dermatology

Phone: 984-974-3900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place