Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment for Actinic Keratosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment.
研究概览
简要总结
This is a randomized, controlled, multi-center trial in subjects diagnosed with Actinic Keratosis (AK) where each subject serves as their own control. The trial will be conducted at 2 sites, one in Germany and one in the United States. Approximately 60 subjects will be randomized to ensure 51 subjects complete the study.
详细描述
The primary objective of this trial is to evaluate the efficacy of the Swift Microwave Treatment on resolution of Actinic Keratosis lesions.
The secondary objectives of this trial is to evaluate the efficacy, safety and tolerability of Swift Microwave treatment as a therapy for Actinic Keratosis (AK).
Eligible subjects who provide written informed consent and have 10, 12 or 14 distinct Actinic Keratosis lesions located on their scalp or hands will be randomized onto the study. Randomization of AK lesions will be stratified by side. Subjects will be randomized to treatment on half the number of AK lesions mapped located on their scalp or hands. The mapped AK lesions not randomized for treatment will receive no treatment (control).
The microwave energy applied by the Swift device will be applied to the randomized AK lesion sites for up to 2 treatments, spaced out by a 4-week interval. Follow-up is 2-months after the first treatment is administered where the AK lesions are assessed for resolution. Further follow-up visits occur at 4-months, 6-months and 12-months after the first treatment was administered where the AK lesions will be assessed for resolution or reoccurence.
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
盲法说明
This is an open label study, however, there is a blinded site investigator at each site who will not be aware of the AK lesions that are randomized to treatment. The blinded site investigator will assess resolution and reoccurrence of the AK lesions. Photos of the AK lesions will be taken and these will be reviewed by three independent blinded assessors to assess cosmetic outcomes.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Age 18-85 years inclusive (EU); 22-85 years inclusive (US).
- •AK lesions for randomization in this study: Clinical diagnosis by a dermatologist of precancerous Actinic Keratosis.
- •Cutaneous location.
- •10, 12 or 14 distinct AK lesions (3-6mm in diameter inclusive), for randomization in this study, located on the subjects' scalp or hands (AK lesions on the scalp and hands for randomization cannot be mixed).
- •There must be at least 2 AK lesions on the left and right side of the scalp or left and right hand.
- •An even number of distinct AK lesions (10, 12 or 14) are to be selected.
- •The maximum possible number of available distinct AK lesions should be selected (10, 12 or 14).
- •The subject may present with any number of AK lesions, however only 10, 12 or 14 distinct AK lesions will be selected for randomization. For example, if a subject presents with 21 AK lesions, an even number of distinct AK lesions are to be selected (i.e. 14 distinct AK lesions with at least 2 distinct AK lesions on the left and right side of the scalp or left and right hand).
- •If currently receiving treatment for Actinic Keratosis, agree to stop their current medication for at least 28 days prior to the start of study treatment.
- •Agrees to refrain from using any other Actinic Keratosis products or treatments during the study period, unless specified by the Investigator.
- •Agrees to refrain from using any topical metallic or ionic treatment (e.g., aluminum chloride, silver nitrate, zinc oxide) during the study period.
- •Free of any disease state or condition which, in the investigator's opinion, could impair evaluation of AK or could expose the subject to an unacceptable risk by study participation.
- •Able to perform study assessments.
排除标准
- •AK lesions at potential treatment sites on lip, nose crease, near eyes or ear.
- •Confluent AK associated with field change at potential treatment sites.
- •Fewer than 2 AK lesions on the left and right side of the scalp or left and right hand.
- •AK lesions at potential treatment sites assessed as clinically ambiguous.
- •Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable electronic devices.
- •Metal implants at site of treatment.
- •Known allergy or intolerance to microwave therapy.
- •Unstable co-morbidities (cardiovascular disease, active malignancy, vasculopathy, inflammatory arthritis).
- •Previous history of skin cancer in the study treatment or observation area.
- •Previous history of squamous cell carcinoma (SCC) or keratoacanthoma (KA) in any location.
- •Pregnancy or breast feeding.
- •Participating in another interventional study or have done so within the last 30 days.
- •Anticipated relocation or extensive travel outside of the local study area preventing compliance with study procedures.
- •Circulatory conditions affecting the acral areas - peripheral vascular disease, peripheral ischemia, vasculitis, Raynaud's, or related conditions.
- •Peripheral neuropathy.
- •Subject who is immunosuppressed (organ transplant recipients, hematologic malignancies, HIV).
- •Subject who has had any topical metallic or ionic treatment (e.g, aluminum chloride, silver nitrate, zinc oxide) within the last 6 months at potential treatment sites.
- •Subjects with AK on the scalp and who have hearing aid(s) and are unable or unwilling to remove hearing aids prior to microwave treatment.
结局指标
主要结局
Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment.
时间窗: 2 months post first treatment
Definition: Treatment Success: complete clearance of ≥75% Actinic Keratosis lesions treated per subject, i.e., at least 75% of the AK lesions treated are fully cleared (not partially cleared).
次要结局
- Severity and occurrence of Adverse Events(Up to 12 months post first treatment)
- Proportion of subjects with reoccurrence of any Actinic Keratosis lesions at 6 months, as classified by the blinded site investigator. The subject's AK lesion must be classified as completely resolved at 2 months to be considered a reoccurrence.(6 months post first treatment)
- Difference in cosmetic outcomes between treated and non-treated Actinic Keratosis as classified by the independent blinded assessors using a grading system(2, 4 and 6 months post first treatment)
- Proportion of subjects with 100% clearance of Actinic Keratosis following Swift Microwave treatment(2, 4 and 6 months post first treatment)
- Percentage of Actinic Keratosis lesions cleared across all study lesions following Swift Microwave treatment(2, 4 and 6 months post first treatment)
- Level of pain during treatment using a severity scale(Treatment 1 (Day 0), Treatment 2 (Day 28))
- Evaluation of Quality of Life (QoL) questionnaires at baseline and 6 months post first treatment using the Dermatology Life Quality Index (DLQI) questionnaire(Baseline and 6 months post first treatment)
- Long term follow-up of subjects with reoccurrence at 12 months as classified by the blinded site investigator(12 months post first treatment)
- Proportion of subjects with treatment success of Actinic Keratosis following Swift Microwave treatment.(4 and 6 months post first treatment)
- OCT Analysis as assessed by an AK Classification System(Baseline and 2, 4 and 6 months post first treatment)
- Evaluation of Patient Reported Outcome (PRO) at baseline and 6 months post first treatment using a rating scale(Baseline and 6 months post first treatment)
- Evaluation of Cosmetic Outcome at 6 months post first treatment using a rating scale(6 months post first treatment)
- Level of pain after treatment using a severity scale(Treatment 1 (Day 0), Treatment 2 (Day 28))
- Duration of pain after treatment using a time period scale(Treatment 1 (Day 0), Treatment 2 (Day 28))