Evaluating the Effect of an Antioxidant Nutraceutical on Skin Health, as Measured by Investigator Global Assessment, Quality-of-Life, and Corneometry, in Persons With Mild to Moderately Severe Facial Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Botanical Impact on hydration in those with Acne Vulgaris
研究概览
简要总结
Antioxidants have been studied for their abilities to combat reactive oxygen species in a multitude of conditions. This study aims to assess whether the botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB), taken orally daily for 8 weeks, can assist with Acne vulgaris as well as skin hydration and quality of life for those with acne.
详细描述
The study will be a 2-armed investigational trial with one group receiving botanical dietary supplement and one placebo group provided with the similar supplement vehicle. The trial will be double-blind, randomized, parallel-group study. The investigational group will receive the botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB), to be taken orally daily for 8 weeks. Control group participants will receive the HBKB botanical dietary supplement vehicle as a placebo to be taken orally daily for 8 weeks.Participants will have their skin assessed
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18-35 years of age able to provide consent to participate
- •IGA of mild to moderately severe facial Acne Vulgaris (AV) at screening
- •Potential participants with mild to moderately severe facial AV and with AV on their neck, shoulders, chest and/or back body surface areas may be included.
排除标准
- •An Investigator Global Assessment IGA of severe facial, neck, back or truncal AV
- •Diagnosis of a chronic inflammatory disease such as lupus, multiple sclerosis, cancer, Chron's disease or cancer
- •Allergies to Astaxanthin (microalgae), Grape Seed Extract, Kiwi fruit or Kiwi extract, Pineapple fruit or extract (bromelain), Rosehip or Rosehip extract, Gooseberry, Rosehip, Grapes
- •Secondary AV, such as occupational AV, steroid induced AV, or AV associated with endocrine disorders
- •Having facial dermatosis that may interfere evaluations by IGA such as sunburn, eczema, psoriasis, erythematotelangectatic rosacea or seborrheic dermatitis
- •Use of isotretinoin within 2 months
- •Use of adapalene or tretinoin within 2 weeks
- •Use of anti-biotics within 2 weeks
- •Use of oral corticosteroids or androgens within 2 weeks
- •Use of anticonvulsants
- •Any subject who the PI deems unsuitable for any reason
结局指标
主要结局
Botanical Impact on hydration in those with Acne Vulgaris
时间窗: 8 weeks
To prospectively appraise changes in stratum corneum hydration levels in persons with Acne Vulgaris (AV) after dietary supplementation with a compilation of botanical antioxidants.
次要结局
- Botanical Impact on Acne Vulgaris(8 weeks)
- Botanical Impact on Quality of Life in those with Acne(8 weeks)
研究者
Zhaoping Li
Professor of Medicine
University of California, Los Angeles