Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque
研究概览
简要总结
This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
详细描述
A Phase 2, pilot, proof-of-concept, open label, single arm prospective study to assess the safety, tolerability and efficacy of using crisaborole 2% ointment for adult morphea. Patients identified by their physician, nurse, or other member of their clinical care team as meeting criteria for the study will be asked to apply crisaborole 2% ointment, twice daily, on affected plaques for 12 weeks. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. Dermal thickness will be measured and compared before and at the end of treatment. Patients will have a clinical assessment at baseline and at weeks 4, 8 and 12. After week 12, patients who need further treatment will undergo standard of care treatment as determined by their primary dermatologist. Physician and patient reported assessment and skin imaging will be performed at baseline, week 4, 8 and 12, and at week 20. Photography will also be performed at baseline and week 12. An optional post treatment follow-up will be performed at week 20.
Medication will be provided free of charge by Pfizer, as part of the grant that is funding this study. These will be dispensed by the study group at baseline and during the subsequent clinic visits.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age
- •Clinical diagnosis of morphea.
- •<20% Total body surface area involvement.
- •Does not require systemic immunosuppressive therapy for morphea.
- •No immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone >=10 mg PO daily).
- •No immunomodulating topical therapy (topical steroids or topical calcineurin inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.
- •No allergy to crisaborole or vehicle.
- •No known renal disease
- •Able to give informed consent.
排除标准
- •Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
- •Clinical diagnosis of depression or history of suicidal ideation.
- •Pregnant or breastfeeding women, with pregnant women being defined as the state of a female after conception until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test. Women with a positive urine hCG at any time during the study will be withdrawn from the study.
研究组 & 干预措施
Crisaborole 2% ointment
Crisaborole 2% ointment applied to affected skin twice per day.
干预措施: Crisaborole (Drug)
结局指标
主要结局
Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque
时间窗: Baseline, 12 weeks
Change in dermal thickness on skin biopsy. A sentinel plaque will be selected at baseline. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque.
次要结局
- Percentage of Reduction in DIET Score of Sentinel Plaque(Baseline and 12 weeks)
- Percentage of Reduction in LoSCAT Score(Baseline,12 weeks)
- Percentage of Reduction in Skindex-29 Score(Baseline and 12 weeks)
- Change in Dermal Thickness of Sentinel Plaque by Ultrasonography(Baseline, 4, 8 and 12 weeks, optional at 20 weeks)