Double-Blind Study Determining the Efficacy of CannaXR in Decreasing UVA Premutagenic and Photoaging Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Title: Double-Blind Study to measure and compare the Mean Percent Reduction UVA induced premutagenic and photoaging markers 8-oxo-dG and the common deletion in 20 subjects treated with CANNAXR and Vehicle and exposed to 3X their individual MED-UVA
研究概览
简要总结
Ultraviolet light A (UVA) causes oxidization of guanine to mutagenic 8-Oxoguanine (8-OxoG) and the most frequent and best characterized mutation in mitochondrial DNA (mtDNA), a deletion of 4,977 base pairs, called the "common deletion", a marker of photoaging.
详细描述
Evaluations & Schedule:
Clinical phase:
The study of each subject will last 4-5 weeks, with 7 visits (Screening visit 1, Baseline visit 2, Follow up visit 3, Follow up visit 4, Follow up visit 5 and Follow up/Final Visit 6).
Screening Visit:
Subjects will read and be explained the informed consent. Subjects who agree to participate will sign the informed consent and a copy will be given to them. Exclusion/inclusion criteria will be reviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Subjects will receive sufficient CANNAXR cream (CANNAXR pods filled with CBD) and VEHICLE cream (cream with empty CANNAXR pods without CBD) in pump containers, marked right or left. Contents of pump containers unknown to subjects and investigators. All 20 subjects are treated with CANNAXR and Vehicle and the exposed to 3X their individual MED-UVA. The masking relates to which hip (right or left) of each individual receives which treatment, CANNAXR or Vehicle. Therefore there is masking of the treatments of all 20 subjects receiving both treatments, considered by clinicaltrial.gov a single arm study.
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Population:
- •Inclusion criteria:
- •Healthy subjects
- •22-65 years of age
- •Fitzpatrick skin types II and III
排除标准
- •Pregnancy
- •Personal history of skin cancer
- •History of abnormal photosensitivity
- •Tobacco smoker
- •History or being exposed to other forms of radiation (other than sunlight)
- •Using any drug/medication that might alter the response of skin to UVA irradiation
- •Unable to undergo skin biopsies
- •History of abnormal scarring
- •History of exposure to the treated areas with external beam X-ray or non-solar UV light irradiation
研究组 & 干预措施
Loaded CANNAXR
In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks.
In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks.
干预措施: In a double-blinded fashion, 250 mg CANNAXR cream (Device)
Loaded CANNAXR
In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks.
In a double-blinded fashion, 250 mg CANNAXR cream and 250 mg VEHICLE cream will be randomized for application to a delineated 50 cm2 area of either the left or right, hip/buttocks skin twice daily for 2 weeks.
干预措施: Topical VEHICLE cream (Device)
结局指标
主要结局
Title: Double-Blind Study to measure and compare the Mean Percent Reduction UVA induced premutagenic and photoaging markers 8-oxo-dG and the common deletion in 20 subjects treated with CANNAXR and Vehicle and exposed to 3X their individual MED-UVA
时间窗: 2 weeks
Determining the Efficacy of topically applied CANNAXR cream vs vehicle cream in decreasing UVA induced Premutagenic and Photoaging markers 8-oxo-dG and the common deletion in 20 subjects exposed to 3X their individual MED-UVA: Comparison of mean percent reduction in UVA induced 8-Oxo-DG and common deletion in CANNAXR and Vehicle treated skin and exposed to 3X MED-UVA
次要结局
未报告次要终点