Trial Outcomes & Findings for Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa (NCT NCT04582669)
NCT ID: NCT04582669
Last Updated: 2023-11-13
Results Overview
Numeric Rating Scale is a pain scale scored with whole integers from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable". Higher score indicates worse pain.
TERMINATED
PHASE4
11 participants
Baseline, Days 2, 6, 14, and 28
2023-11-13
Participant Flow
Participant milestones
| Measure |
Sodium Chloride 0.9%
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Intralesional Triamcinolone 10 mg/mL
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 20 mg/mL
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 40 mg/mL
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Sodium Chloride 0.9%
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Intralesional Triamcinolone 10 mg/mL
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 20 mg/mL
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 40 mg/mL
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
|---|---|---|---|---|
|
Overall Study
Subject missed appointment(s).
|
1
|
0
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Sodium Chloride 0.9%
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Intralesional Triamcinolone 10 mg/mL
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 20 mg/mL
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 40 mg/mL
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age 20-29 years old
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Customized
Age 30-39 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
Age 40-49 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Customized
Age 50-59 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Age 60-69 years old
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Days 2, 6, 14, and 28Population: NRS scoring data was not collected and aggregated and/or analyzed at any of the identified timepoints.
Numeric Rating Scale is a pain scale scored with whole integers from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable". Higher score indicates worse pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: HS-PGA scoring data was not collected and aggregated and/or analyzed at any of the identified timepoints.
HS-PGA is a six-staged physician global assessment tool (score ranges from 0 to 5) based on number of HS lesions including inflammatory and/or non-inflammatory nodules, abscesses, and draining fistulas. Higher HS-PGA score indicates more severe HS disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: CRP data was not collected and aggregated and/or analyzed at any of the identified timepoints. Laboratory analyses were not conducted.
CRP (measured in mg/dL) is an inflammatory marker. A higher value is correlated with more severe disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: HS lesion size data was not collected and aggregated and/or analyzed at any of the identified timepoints.
HS lesion size will be measured using a metric ruler in centimeters. Measurement will be standardized according to greatest diameter as lesions will be measured from edge of one border to the edge of the opposite border.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Days 2, 6, 14, and 28Population: PROMIS data was not collected/aggregated and therefore not analyzed at any of the identified timepoints.
Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered outcome measures that assesses physical, mental, and psychosocial health in adults and children. Clinical measures of health outcome includes physical function, mobility, pain, fatigue, emotional stress, ability to participate in social roles, sleep-related impairment, depressive symptoms/sadness, anxiety/fear, and anger. The scores are rated on a scale from 0 to 100 with "0" being "best functioning" and "100" being "worst functioning".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineEvaluate the morphologic changes in participant's skin from baseline, specifically assessing 1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas. 3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome measures
| Measure |
Sodium Chloride 0.9%
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Intralesional Triamcinolone 10 mg/mL
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 20 mg/mL
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 40 mg/mL
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2Population: There were two fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing 1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas. 3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome measures
| Measure |
Sodium Chloride 0.9%
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Intralesional Triamcinolone 10 mg/mL
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 20 mg/mL
n=1 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 40 mg/mL
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 6Population: There was one fewer subject than baseline because subject did not meet eligibility criteria, and data was not collected and/or analyzed.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing 1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas. 3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome measures
| Measure |
Sodium Chloride 0.9%
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Intralesional Triamcinolone 10 mg/mL
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 20 mg/mL
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 40 mg/mL
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: There were four fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing 1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas. 3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome measures
| Measure |
Sodium Chloride 0.9%
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Intralesional Triamcinolone 10 mg/mL
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 20 mg/mL
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 40 mg/mL
n=3 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: There were six fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing 1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris 2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas. 3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Outcome measures
| Measure |
Sodium Chloride 0.9%
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
|
Intralesional Triamcinolone 10 mg/mL
n=2 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 20 mg/mL
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
|
Intralesional Triamcinolone 40 mg/mL
n=1 Participants
Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ESR data was not collected/aggregated and therefore not analyzed at any of the identified timepoints. Laboratory analyses were not conducted.
ESR (measured in mm/h), is a pro-inflammatory marker. Higher ESR levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Patient satisfaction data was not collected/aggregated and therefore not analyzed.
Likert scale is a rating system that is designed to measure participant's overall attitude and perception regarding one's health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 2, 6, 14, and 28Population: Change from baseline data for patient satisfaction was not collected/aggregated and therefore not analyzed at any of the identified timepoints.
Likert scale is a rating system that is designed to measure participant's overall attitude and perception regarding one's health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: IL-6 data was not collected/aggregated and therefore not analyzed at any of the identified timepoints. Laboratory analyses were not conducted.
IL-6 (measured in pg/mL), is a pro-inflammatory cytokine. Higher IL-6 levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.
Outcome measures
Outcome data not reported
Adverse Events
Sodium Chloride 0.9%
Intralesional Triamcinolone 10 mg/mL
Intralesional Triamcinolone 20 mg/mL
Intralesional Triamcinolone 40 mg/mL
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place