A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 7
- 主要终点
- Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
研究概览
简要总结
This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.
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
- 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
- •Must be male or female and at least 18 years of age
- •Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
- •Ability to provide informed consent
- •primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision
排除标准
- •location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area.
- •Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit.
- •Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit
- •Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area.
- •Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks
- •Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit.
- •Use of systemic retinoids.
- •Those who are currently participating in any other clinical trial
- •Those known or suspected of not being able to comply with the requirements of the protocol
- •Females who are pregnant or are breastfeeding
研究组 & 干预措施
Group 1
PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days
干预措施: PEP005 (ingenol mebutate) Gel, 0.05% (Drug)
Group 1
PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days
干预措施: Aluminium disk (Device)
Group 2
PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days
干预措施: PEP005 (ingenol mebutate) Gel, 0.05% (Drug)
Group 2
PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days
干预措施: OpSite(TM) disk (Device)
Group 3
PEP005 0.05% applied with no occlusion for up to three consecutive days
干预措施: PEP005 (ingenol mebutate) Gel, 0.05% (Drug)
结局指标
主要结局
Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring
时间窗: 120 days
Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring.
次要结局
- Histological and clinical clearance of sBCC lesions.(120 days)