An Open-label Proof of Concept Study Regarding the Efficacy and Safety of Dupilumab in the Treatment of Keloids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
The study investigates the efficacy and safety of dupilumab in the treatment of keloids
详细描述
Current scar treatments have limited efficacy and are often unsatisfactory although over $20 billion dollars are spent annually on the treatment and management of scars. Keloids, an abnormal proliferation of scar tissue, can be disfiguring, functionally impairing, and have dramatic impacts on quality of life. Treatments of keloids include a variety of modalities (i.e. intralesional steroid injections, silicone gel or sheets, surgery, laser, radiation therapy, cryotherapy, topical imiquimod, and intralesional 5-fluorouracil injections). However, current treatments are limited to primarily localized interventions.
The Investigators hypothesize that dupilumab can decrease the size and symptoms of keloids and improve patient's quality of life. An open-label proof of concept study regarding the use of dupilumab in patients with keloids may be the first step in elucidating a novel systematic approach to treatment of keloids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 65 at the time of dupilumab initiation.
- •Subjects must have either one keloid with ≥ 2 cm length-wise or at least two keloids with ≥ 0.4 cm (width) x 0.4 cm (length)
- •Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.
排除标准
- •History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (Tb) infection as defined by a positive QuantiFERON TB-Gold test at screening.
- •Known infection with HIV, hepatitis B or hepatitis C at screening.
- •Are currently pregnant, breastfeeding, or planning to get pregnant during the study.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 8 weeks after stopping treatment. Methods of acceptable birth control are listed below under "Women of Childbearing Potential"
- •Previous hypersensitivity reaction to dupilumab.
- •Patients with acute asthma, acute bronchospasm or status asthmaticus.
- •Patients with known helminth infections.
- •Currently on any other immunosuppressant systemic medication or within 28 days of baseline visit.
- •Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
- •Are participating in another study using an investigational agent or procedure during participation in this study or within 28 days prior to baseline visit.
- •Any other treatment for keloids with 28 days prior to baseline visit, including silicone gel/sheets, laser therapy, intralesional steroid or 5-fluorouracil injections, topical steroid, cryotherapy, surgery, or radiation therapy.
- •Has had a live vaccine
研究组 & 干预措施
Dupilumab Subcutaneous Injection
600 mg at initial visit and 300mg every 2 weeks until week 22
Each subject will receive 600mg of Dupilumab at baseline visit and 300mg of Dupilumab as a subcutaneous injection every 2 weeks for a total of 9 doses over 22 weeks.
干预措施: Dupilumab (Drug)
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS)
时间窗: Baseline and Week 24
Average patient scores for Patient and Observer Scar Assessment Scale (POSAS) from baseline and week 24. The POSAS measures scar quality by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer (investigator) and patients. POSAS is comprised of two numeric scales: the Patient Scar Assessment Scale (PSAS, patient scale measuring pain, pruritus, color, stiffness, thickness, bumpiness) and the Observer Scar Assessment Scale (OSAS, observer scale measuring vascularity, pigmentation, thickness, relief, pliability, surface area). Both scales contain six items that are scored numerically on a 1-10 scale. A score of "1" being "no, not at all" and a score of "10" being "yes, very much". Together, they make up the total score (range of 12-120) of the PSAS (range of 6-60) and OSAS (range of 6-60).
次要结局
- Vancouver Scar Scale (VSS).(Baseline and Week 24)
- Dermatology Life Quality Index (DLQI).(Baseline and Week 24)
- Histology(Baseline and Week 24)
- Number of patients with keloid volume and size improvement(Baseline and Week 24)
研究者
Martina Porter
MD
Beth Israel Deaconess Medical Center