Investigation of Local Skin Reactions and Safety After Combined Treatment of Basal Cell Carcinoma Using Ablative Fractional Laser and Ingenol Mebutate - an Exploratory, Prospective, Open-label Phase 2a Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in occurrence of local skin reactions
研究概览
简要总结
A prospective clinical, uncontrolled, open-label, explorative phase 2a trial on patients with histologically-confirmed superficial and nodular basal cell carcinoma (BCC). The study assesses tolerability and tumor clearance after laser-assisted topical delivery of topical ingenol mebutate.
详细描述
Patients will receive ablative fractional laser (AFXl)-assisted ingenol mebutate (IM) as a treatment for their cutaneous basal cell carcinoma (BCC). Treatment areas consisting of tumors and a 5 mm margin will undergo AFXl exposure (CO2 laser) followed by IM 0.015% or 0.05% under occlusion for 2-3 days. .
local skin reactions are monitored at baseline (day1), day 3/4, day 8, day 15, day 29, day 90, and tumor response monitored at baseline, day 29, and day 90. An additional repeat AFXl-IM treatment on day 29 will be offered if tumors persist, based on clinical evaluation and imaging on day 30.
Primary outcome:
- severity and duration of clinical local skin reactions including erythema, scaling, edema, blistering, erosion/ulceration and crusting using a 0-4-point scale at all visits from baseline to day 90.
- To monitor BCC tumor response on clinical assessments supported by non-invasive imaging techniques including optical coherence tomography (OCT) and reflectance confocal microscopy (RCM) at baseline, day 29 and day 90.
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
- •Subjects who meet all of the following criteria are eligible to participate in this study
- •Patients with histologically verified, low-risk, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk
- •> 18 years of age at baseline
- •Legally competent, able to give verbal and written consent
- •Communicate in Danish verbally as well as in writing
- •Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements.
- •Fitzpatrick skin phototype I-III
- •Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
排除标准
- •Subjects meeting any one of the following criteria are not eligible to participate in this study
- •Patients with
- •o High-risk BCC
- •Tumors on the following anatomical locations:
- •Midface region
- •Orbital areas
- •ii. Size:
- •> 20 mm in facial/scalp areas
- •> 50 mm in non-facial/non-scalp areas
- •Morpheaform
- •Medical history
- •Gorlin syndrome
- •o Immunosuppressive medication
- •Subjects with a known allergy to IM.
- •Individuals with other skin diseases in the area of research interest
- •Subjects with tattoo in the treatment area which may interfere with or confound evaluation of the study
- •Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator
- •Subjects with Fitzpatrick skin phototype IV-VI
- •Lactating or pregnant women
研究组 & 干预措施
Arm
Basal cell carcinoma (BCC) patients Patients (>18 pr) with histologically-verified superficial or nodular basal cell carcinoma (<20 mm on face/scalp, <50 mm on trunk/extremities)
干预措施: AFXl-assisted ingenol mebutate delivery (Drug)
结局指标
主要结局
Change in occurrence of local skin reactions
时间窗: 0-90 days
Non-blinded, clinical evaluation of local erythema, edema, flaking, crusting/scabbing, pustulation, scarring, hypo(hyperpigmentation, infection in treated areas will be performed by physician using an FDA-approved 0-4 point lsr scale at day 1, 3/4, 8, 15, 29 and 90 after AFXl exposure. Standardized, clinical photographs are taken to document skin reactions at each visit
次要结局
- Tumor response clinically(baseline, day 29, day 90)
- Tumor response by imaging techniques(baseline, day 29, day 90)
- Tumor response - histology(At day 90)
研究者
Merete Haedersdal
Professor, Senior Consultant, PhD, DMSc
Bispebjerg Hospital