NCT06362889尚未招募1 期
An Exploratory Study to Evaluate the Safety and Efficacy of Microneedling With Cannabidiol (CBD) and Hempseed Oil for Treating Acne Vulgaris
Rejuva Medical Aesthetics2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Primary efficacy endpoints
研究概览
简要总结
This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-lactating female, 22 years of age or older. Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
- •Have a Global Acne Severity Scale Score of 3 (Moderate), 4 (Severe), or 5 (Very severe).
- •Have no plans to begin a new skincare routine or medical treatment program (Accutane) through the course of the study.
- •Willing to abstain from any aesthetic or surgical procedure in the treatment area for the duration of the study.
排除标准
- •Significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the investigator, would put the subject at undue risk or compromise the study assessments.
- •Employees of the Investigator or research center or their immediate family members.
- •Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
- •The use of Accutane (Isotretinoin) within 6-months.
- •The use of topical or oral therapies that include benzoyl peroxide, azelaic acid, salicylic acid, and hydroquinone 30 days prior to study entry.
- •Exposure to any other investigational drug/device within 30 days prior to study entry.
- •Sunburned at time of anticipated treatment. Subject must also be willing to avoid significant sun exposure throughout participation
- •Recent facial plastic surgery, aesthetic treatment, or dermatological treatment at treatment sites that would interfere with ability to receive microneedling.
- •Facial hair that would interfere with the visualization of treatment sites.
- •Subject with abnormal vision assessments.
- •Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g. due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
结局指标
主要结局
Primary efficacy endpoints
时间窗: through study completion, approximately 70 days
Reduction in the Global Acne Severity Scale (GAS) grade by Primary Investigator Reduction in the GAS grade by the Subject
次要结局
- Secondary efficacy endpoints(through study completion, approximately 70 days)
研究者
研究点 (2)
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