Tolerability Study of the Application of a 3M Microstructure Transdermal System by Finger Pressure to the Face in Healthy Subjects Stratified by Age and Fitzpatrick Skin Type
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Median pain scores
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of an experimental device that introduces microscopic channels into the skin. Creating microscopic channels in the skin allows for better absorption of various medications applied to the skin, and this study will determine if the study device offers a tolerable method by which to introduce these holes. The study population will include 54 individuals, ages 18-74 years old, with a roughly equal distribution of skin colors. Each subject will have a total of three visits 24 hours apart from one another. The study device will be applied at the Baseline and Day 1 visits. At various timepoints before and after device application, skin assessments for irritation will be completed using a 7-point Skin Reaction Scale and photographs will be taken. Subjects will report pain associated with device application using a standardized pain scale. At the baseline visit, a member of the research staff will administer applications of the study device on the side of the subject's forehead, temple and the area below and to the side of the nose on randomly selected sides of the face. The side of the face at each location not receiving application of the study device will receive applications of a "dummy" device. Subjects will not be informed of which device is the study device and which is the "dummy" device. At the Day 1 visit, a member of the research staff will administer study device applications to the center of the subject's forehead. The subject will also self-apply the study device to the chin, under the instruction of the research staff member. At the Day 2 visit, final skin assessments will be made and the subject will be evaluated and treated for any persistent skin irritation. Differences in skin irritation between sites of study device application and "dummy" device application will be determined, as well as several other endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-74 years old
- •Subject in good health as determined by the investigator
- •Subject has the willingness and the ability to understand and provide informed consent and communicate with the investigator
排除标准
- •Subjects with active systemic or skin disease (including acne) or skin infection that could, in the opinion of the investigator, interfere with accurate study assessments
- •Baseline skin irritation as defined by a local skin reaction score greater than "0" at any of the application areas (Appendix 1)
- •Facial cosmetic procedures performed within 4 weeks of the baseline visit that may, in the opinion of the investigator, have an impact on skin assessment results†
- •Topical medications applied to the face within 2 weeks of the baseline visit that may, in the opinion of the investigator, have an impact on skin assessment results†
- •Subjects with skin disease such as atopic dermatitis, urticaria or dermatographism that may be exacerbated by device application †Subjects may enroll after a corresponding washout period
研究组 & 干预措施
Study device
The study device is a transdermal microneedle array designed to introduce microscopic channels into the skin. The study device arm will receive application of this device.
干预措施: Transdermal Microchannel Skin System (Device)
Sham device
The sham device will be very similar in appearance to the study device. The sham device arm will receive application of this device.
干预措施: Sham device (Device)
结局指标
主要结局
Median pain scores
时间窗: 5 minutes
Difference in median pain scores between Study Device side and Control side for any of the three facial application sites.
Local skin reaction and reported pain central forehead
时间窗: 24 hours
Reported pain and change in skin irritation at the central forehead site.
Local skin reaction scores
时间窗: 48 hours
Difference in median local skin reaction scores between Study Device side and Control side for any of the three facial application sites at any of the seven follow-up times.
Local skin reaction score and reported pain chin
时间窗: 24 hours
Reported pain and change in skin irritation at the chin site.
次要结局
- Max difference in skin reaction score(48 hours)
- Differences between skin type groupings(48 hours)
- Subject questionnaire differences(48 hours)
- Differences between age groups(48 hours)
研究者
Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University