NCT01541553已完成3 期
A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 367
- 试验地点
- 35
- 主要终点
- Complete Clearance of AKs at Week 11
研究概览
简要总结
The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
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, Investigator)
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
- •Subjects must be competent to understand the nature of the trial and provide informed consent.
- •Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp.
- •Subject at least 18 years of age.
- •Female subjects must be of either:
- •Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
- •Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy.
- •Female subjects of childbearing potential must be willing to use effective contraception.
排除标准
- •Location of the selected treatment area:
- •on any location other than the face or scalp
- •within 5 cm of an incompletely healed wound
- •within 10 cm of a suspected basal cell carcinoma (BCC) or SCC
- •Prior treatment with PEP005 Gel on face or scalp.
- •Selected treatment area lesions that have:
- •atypical clinical appearance and/or
- •recalcitrant disease
- •History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication
- •Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy.
- •Any abnormal vital signs measurements that are medically significant or would impact the safety of the subject or the interpretation of the trial results.
- •Anticipated need for hospitalization or out-patient surgery during the first 15 days after the first trial medication application.
- •Known sensitivity or allergy to any of the ingredients in PEP005 Gel
- •Recent excessive exposure to ultraviolet light
- •Current enrolment or participation in a clinical trial within 30 days of entry into this study
- •Subjects previously randomised in the trial
- •Female subjects who are breastfeeding
- •Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1
- •Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
- •Use of acid-containing therapeutic products within 2 cm of the selected treatment area
- •Use of topical medicated creams, ointments, lotions, gels, foams or sprays
- •Prohibited Therapies and/or Medications: within 4 weeks prior to visit 1:
- •Treatment with immunomodulators, cytotoxic drugs or inter-feron /interferon inducers
- •Treatment with systemic medications that suppress the immune system
- •Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB).
- •Prohibited Therapies and/or Medications within 8 weeks prior to visit 1:
- •Treatment with 5-FU, imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area.
- •Prohibited Therapies and/or Medications within 6 months prior to visit 1
- •Use of systemic retinoids or biologic / mono-clonal antibody therapies
研究组 & 干预措施
PEP005 Gel, 0.015%
Active Comparator
Cryotherapy followed by PEP005 Gel, 0.015%
干预措施: Cryotherapy (Procedure)
PEP005 Gel, 0.015%
Active Comparator
Cryotherapy followed by PEP005 Gel, 0.015%
干预措施: Ingenol metabute (Drug)
Vehicle gel
Placebo Comparator
Cryotherapy followed by vehicle gel
干预措施: Cryotherapy (Procedure)
Vehicle gel
Placebo Comparator
Cryotherapy followed by vehicle gel
干预措施: Vehicle (Drug)
结局指标
主要结局
Complete Clearance of AKs at Week 11
时间窗: 11 weeks
To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
次要结局
- Percentage Change From Baseline in Number of AKs at Week 11(Baseline to week 11)
- Partial Clearance of AKs at Week 11(Week 11)
研究者
研究点 (35)
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