NCT01600014已完成3 期
Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on 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
- 463
- 试验地点
- 13
- 主要终点
- Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation
研究概览
简要总结
The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.
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 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 consent to using highly effective methods of contraception
排除标准
- •Location of the selected treatment area:
- •on any location other than the face or scalp
- •on the periorbital skin
- •within 5 cm of an incompletely healed wound
- •within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
- •Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on trunk and extremities acceptable)
- •Selected treatment area lesions that have atypical clinical appearance
- •History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
- •Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle
- •Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
- •Presence of sunburn within the selected treatment area
- •Current enrollment or participation in a clinical trial within 30 days of entry into this study
- •Subjects previously entered first treatment in the trial
- •Female subjects who are breastfeeding
- •Subjects who are institutionalised by court order or by the local authority
- •In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol
- •Prohibited Therapies and/or Medications within 2 weeks prior to Day 1
- •Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
- •Use of keratolytic topical therapeutic products within 2 cm of the selected treatment area
- •Use of topical medicated creams, ointments, lotions gels, foams or sprays within 2 cm of the selected treatment area; artificial tanners: within 5 cm of the selected treatment area
- •Prohibited Therapies and/or Medications: within 4 weeks prior to Day 1
- •Treatment with immunomodulators, cytotoxic drugs or interferon /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 Day 1
- •Treatment with 5-fluorouracil (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 Day 1
- •Use of systemic retinoids or biologic/monoclonal antibody therapies
研究组 & 干预措施
Ingenol mebutate gel, 0.015%
Active Comparator
Topical field treatment once daily for 3 consecutive days on the face or scalp
干预措施: Ingenol mebutate gel, 0.015% (Drug)
Vehicle gel
Placebo Comparator
Topical field treatment once daily for 3 consecutive days on the face or scalp
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation
时间窗: 8 weeks after randomisation
The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)
次要结局
- The Change in AK Count From Randomisation to 8 Weeks After Randomisation(8 weeks after randomisation)
- Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12(From last treatment cycle through to Month 12)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or ChestActinic KeratosisNCT02361216LEO Pharma729
进行中（未招募）
1 期
Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.Actinic keratosis on the face or scalpMedDRA version: 18.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2014-003218-98-DEEO Pharma A/S500
进行中（未招募）
1 期
Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.Actinic keratosis on the face or scalpMedDRA version: 17.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2014-003218-98-GBEO Pharma A/S502
进行中（未招募）
1 期
Efficacy and safety of ingenol mebutate gel 0.015% compared to diclofenac sodium gel 3% in subjects with actinic keratoses on the face or scalp.EUCTR2014-003218-98-ESEO Pharma A/S500
已完成
4 期
Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs CryotherapyActinic KeratosisNCT02990221University of Campania "Luigi Vanvitelli"50