Acne Vulgaris Blemish Full Spectrum Hemp Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Facial Blemishes
研究概览
简要总结
In westernized societies, acne vulgaris is nearly a universal skin disease afflicting 79% to 95% of the adolescent population; older than 25 years - 40% to 54% have facial blemishes and persists into middle age in 12% of women and 3% of men. Standard treatment modalities present with high risk morbidities. Charlotte's Web hemp blemish product is predicted to significantly reduce the risks mentioned above, while improving efficacy as well as imparting other skin benefits.
详细描述
Charlotte's Web Full spectrum hemp blemish product will contain a mere 0.018% THC and will therefor not impart a psychotic affect. Hemp has been shown to be well tolerated in humans and has a very acceptable dosage, efficacy and safety profile when topically applied. The FDA has labeled hemp as Generally Regarded As Safe (GRAS) and as such reduces the risk of severe adverse reactions to the subject.
Benefits of hemp blemish 'cream" is that it has been formulated in such a way as to promote natural skin balance, and may eliminate skin dryness, inflammation, hyperpigmentation, and scaring.
The primary objective and endpoint of the study is to obtain total eradication of the blemish eruptions. The secondary objective and endpoints is the continued use of the hemp product will continue to prevent further blemish eruptions and provide other skin benefits especially reducing the propensity to scar.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female
- •Diagnosed acne vulgaris
- •Not on current acne treatment(s) or off current treatment for 2 weeks
- •13-70 yrs old
排除标准
- •Not willing to stop current acne treatment(s)
- •males that present with facial hair
- •active TB, HIV or hepatitis
- •pregnant or lactating females
研究组 & 干预措施
Age, Male, Female, ethnicity,
The aim of the study is to be inclusive of all groups as to avoid bias. Furthermore, the study aims to determine if its formulation will encompass all skin types, genders and age groups.
Full-spectrum hemp dosage is determined to begin with 40mg - 2-3X/day = topical application; for a period of 2-3 months.
Drug: Full Spectrum hemp (0.018% THC), Topical Application Placebo = cream without hemp (Double blinded) One cream will be placed on one side of the face (R/L) and the other cream on the other side of the face.
干预措施: Full-spectrum hemp (0.018% THC) (Drug)
结局指标
主要结局
Facial Blemishes
时间窗: 2-3 months
Total eradication of of acne vulgaris/blemishes with reduction of inflammation
次要结局
- Improvement of overall skin tone(2-3-6 months)