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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04582669
Other study ID # 2020-12227
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date January 24, 2022
Est. completion date October 12, 2022

Study information

Verified date October 2023
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Currently, there is limited evidence showing increased resolution of HS flares with higher doses of intralesional triamcinolone (ILTAC) as well as a difference in side effect profile between the doses. The goal of this study is to determine the efficacy of treating HS flares with ILTAC-10, ILTAC-20 and ILTAC-40 and to investigate the side effect profile for each dose.


Description:

A double-blinded, randomized, placebo-controlled study examining the relative efficacy of ILTAC-10, ILTAC-20, and ILTAC-40 versus placebo for acute flares of HS in subjects with moderate to severe HS. The duration of the study will be approximately 4 weeks for each enrolled patient and will include an initial screening/randomization/treatment visit and a 4-week follow-up period. During the initial visit, subjects who meet the study's eligibility criteria will be randomized to receive either ILTAC-10, ILTAC-20, ILTAC-40, or placebo in a 1:1:1:1 ratio. Study subjects will then receive treatment or placebo. The follow-up period will be of 4 weeks and will consist of 3 phone calls and 1 live visit, including an end of study visit on week 4 after randomization.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date October 12, 2022
Est. primary completion date October 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years and older
Eligibility Inclusion Criteria: - Age > 13 years old. - Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board. - Subject is willing to comply with the procedures in this protocol. - The subject must be diagnosed with HS and receiving care at HSC - Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5 - The subject must have an inflamed nodule or abscess at the time of enrollment. Exclusion Criteria: - The subject has an HS-PGA score of 0 or 1 - The subject has received ILTAC less than 8 days prior to the initial visit. - The subject does not have capacity to consent to the study. - The subject is has taken systemic steroids at least 4 weeks prior to the time of enrollment. - The subject has a known allergy or history of adverse reaction to steroids. - The subject is pregnant. - Subjects who have received a biologic therapy two weeks before and during the study period.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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
Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
Intralesional Triamcinolone 40 mg/mL
Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
Placebo
Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.

Locations

Country Name City State
United States Steven Cohen Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Numeric Rating Scale (NRS) 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. Baseline, Days 2, 6, 14, and 28
Secondary Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score 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. Baseline and Week 4
Secondary Change From Baseline in C-reactive Protein (CRP) CRP (measured in mg/dL) is an inflammatory marker. A higher value is correlated with more severe disease. Baseline and Week 4
Secondary Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size 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. Baseline and Week 4
Secondary Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 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". Baseline, Days 2, 6, 14, and 28
Secondary Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline. Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Baseline
Secondary Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline. Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Day 2
Secondary Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline. Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Day 6
Secondary Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline. Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Day 14
Secondary Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline. Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Day 28
Secondary Change From Baseline in Erythrocyte Sedimentation Rate (ESR) 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. Baseline and Week 4
Secondary Baseline Patient Satisfaction Likert Scale 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. Baseline
Secondary Change From Baseline in Patient Satisfaction Likert Scale 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. Days 2, 6, 14, and 28
Secondary Change From Baseline in Interleukin-6 (IL-6) 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. Baseline and Week 4
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