Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change From Baseline in Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: Intralesional Triamcinolone 10 mg/mL (Drug)
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.
干预措施: Intralesional Triamcinolone 20 mg/mL (Drug)
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.
干预措施: Intralesional Triamcinolone 40 mg/mL (Drug)
结局指标
主要结局
Change From Baseline in Numeric Rating Scale (NRS)
时间窗: Baseline, Days 2, 6, 14, and 28
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.
次要结局
- Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score(Baseline and Week 4)
- Change From Baseline in C-reactive Protein (CRP)(Baseline and Week 4)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Baseline and Week 4)
- Change From Baseline in Patient Satisfaction Likert Scale(Days 2, 6, 14, and 28)
- Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size(Baseline and Week 4)
- Baseline Patient Satisfaction Likert Scale(Baseline)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, Days 2, 6, 14, and 28)
- Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.(Day 28)
- Change From Baseline in Interleukin-6 (IL-6)(Baseline and Week 4)