A Clinical Trial Examining the Efficacy of a Novel Acne Treatment Serum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Facial Acne Symptoms
研究概览
简要总结
This single-group, open-label clinical trial examines the efficacy of Cool as a Cucumber's Acne Treatment Serum in adults with acne-prone skin. The study will enroll 25 male and female participants between the ages of 24 and 47 who will use the serum for eight weeks, with assessments conducted virtually at Baseline, Week 4, and Week 8.
The primary objective is to evaluate the effects of the Acne Treatment Serum on facial acne using the Validated Acne Quality-of-Life Scale (Acne QoL) and expert-graded before-and-after photographs. Secondary objectives include evaluating changes in skin texture, uneven skin tone, hyperpigmentation, redness, sebum production, and fine lines and wrinkles via self-reported questionnaires.
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
- 24 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 24-47 (between 2-4 males, the remainder females)
- •Actively has acne (non-inflamed and/or inflamed acne)
- •Has previously used or is currently using exfoliating acids (AHAs / BHA) and is willing to stop this for the duration of the study
- •Has not experienced sunburn on the face in the last month
- •No open wounds, sores, or non-acne related lesions on the face
- •Generally healthy - don't live with any uncontrolled chronic disease
- •Willing to apply SPF on a daily basis during the study and to use other sun protection on the face (i.e. a hat)
- •Must be willing to avoid products with coconut oil and shea butter, and Ethylhexyl Palmitate for the duration of the study
- •Must be willing to cut out whey protein and cow's milk from their diet for the duration of the study
- •Must be willing to avoid biotin products or supplements for the duration of the study
- •Must agree to avoid sun tanning, tanning beds, and self-tanning products for the duration of the study
排除标准
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Anyone with known severe allergic reactions
- •Women who are pregnant, breastfeeding or attempting to become pregnant
- •Unwilling to follow the study protocol
- •Anyone consuming products containing Tetrahydrocannabinol (THC)
- •Identifies as a person with sensitive skin
- •Anyone currently on steroids or undergoing hormone replacement therapy
- •Anyone using prescription medication relevant to the skin
- •Undergoing any cosmetic procedures during the study including facials, Botox, dermal filler, laser, or chemical peel treatments
- •Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (e.g., retinoids, accutane)
- •Anyone allergic to niacinamide or salicylic acid
- •Anyone who regularly consumes biotin supplements and is unwilling to stop for the duration of the study
- •Participants who stopped using birth control within the past 3 months
- •Participants currently have a Copper IUD or are using one of the following birth control high in androgen and low in estrogen activity: Amethyst, Jolessa, Lessina, Levonest/Levora, Lutera, Nordette, Portia, Seasonale/Seasonique, Sronyx, Mirena IUD, Triphasil/Trivora, Cryselle, Lo-Ovral/Ovral, Low-Ogestrel/Ogestrel, Lo-Feminol, Ortho tricyclen Lo, Estrostep Fe, Loestrin, Microgestin, Apri, Mircette, Azurette, Caziant, Cyclessa, Desogen, Emoquette, Kariva, Linessa, Marvelon, NuvaRing, Depo-Provera, Reclipsen
研究组 & 干预措施
Acne Treatment Serum
干预措施: Acne Treatment Serum (Dietary Supplement)
结局指标
主要结局
Change in Facial Acne Symptoms
时间窗: Baseline, Week 4, and Week 8
Mean change in perceived facial acne symptoms assessed via the Validated Acne Quality-of-Life Scale (Acne QoL) self-reported questionnaire
Change in Facial Acne Severity on Photographs
时间窗: Baseline, Week 4, and Week 8
Expert skin grading by a dermatologist of before-and-after selfie photographs to assess visual changes in acne severity
次要结局
- Change in Skin Texture(Baseline, Week 4, and Week 8)
- Change in Skin Tone(Baseline, Week 4, and Week 8)
- Change in Hyperpigmentation(Baseline, Week 4, and Week 8)
- Change in Redness/Inflammation(Baseline, Week 4, and Week 8)
- Change in Sebum Production(Baseline, Week 4, and Week 8)
- Change in Fine Lines and Wrinkles(Baseline, Week 4, and Week 8)