Randomized Double-Blind Study of the Cosmetic Effects of Topical Acetyl Zingerone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in appearance of skin pigmentation
研究概览
简要总结
Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aimed to study the microbial and cosmetic effects of Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.
详细描述
Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aim to study Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.
Both curcumin and Zingerone are from the Zingiberacea family of plants (also known as the ginger family). Both have been widely studied and noted to have antibacterial effects and promote skin health effects. Curcumin has been studied widely in recent years due to various microbial effects. AZ is a derivative that is similar to both Zingerone and curcumin and has been noted to have many different activities including anti-inflammatory, antimicrobial, and antioxidant functions. However, there are no studies looking at how it modulates the skin cosmetically or the superficial microbiome.
The aim of this study was to compare the cosmetic effects of AZ to a vehicle over an 8-week period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Those that have had topical antibiotics within the past 4 weeks
- •Those that have had oral antibiotics within past 4 weeks
- •Those who have used systemic isotretinoin in the last 6 months
- •Those with a known allergy to members of the ginger family
- •Current smokers OR 20 pack-year history of smoking OR Have smoked within the past 3 years
- •Pregnant women
- •Prisoners
- •Those who have had any change to their hormonal birth control regimen in the last 4 weeks.
- •Those with visible signs in the area of application of or on active treatment for cystic acne, eczema, seborrheic dermatitis, papulopustular rosacea at investigator discretion
- •Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser based therapies to the face, or face lift surgeries at investigator discretion
研究组 & 干预措施
Acetyl Zingerone Group
This group was given the topical with the active acetyl zingerone agent.
干预措施: Acetyl Zingerone Topical Cream (Other)
Control Group
This group was given the topical without the active acetyl zingerone agent and just the carrier lotion.
干预措施: Topical cream (Other)
结局指标
主要结局
Change in appearance of skin pigmentation
时间窗: 8 weeks
Change in appearance of image based skin pigmentation from baseline
Change in wrinkle appearance
时间窗: 8 weeks
Change in image based analysis of wrinkle severity from baseline
次要结局
- Appearance of side effects such as scaling or irritation(4 weeks and 8 weeks)
- Change in skin redness (erythema)(4 weeks and 8 weeks)
- Change in wrinkle appearance(4 weeks)
- Change in superficial lipidome diversity(4 weeks and 8 weeks)
- Change in appearance of skin pigmentation(4 weeks)
- Change in superficial microbiome diversity(4 weeks and 8 weeks)