A Human Application Study to Evaluate the Effects of CosmeRNA Brow Revitalizing Serum on Eyebrow Density and Length
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change From Baseline in Eyebrow Density
研究概览
简要总结
This study evaluated the effects of CosmeRNA Brow Revitalizing Serum on eyebrow density and length in healthy Korean adults. Each participant applied the investigational serum to one eyebrow and a control serum to the other eyebrow once daily for 8 weeks. Eyebrow density and length were assessed before product use and after 4 and 8 weeks of use. Product compliance, participant-reported outcomes, and skin adverse reactions were also evaluated.
详细描述
This was an 8-week, within-participant, controlled human application study conducted in healthy Korean adults aged 20 years or older.
For each participant, the face was divided vertically, with one eyebrow assigned to the investigational product and the contralateral eyebrow assigned to the control product. The investigational product was CosmeRNA Brow Revitalizing Serum, and the control product was a vehicle control serum. Participants applied an appropriate amount of each assigned product to the corresponding eyebrow once daily, either in the morning or evening, for 8 weeks.
Eyebrow density was evaluated using Folliscope 5.0. Images of the eyebrow areas were obtained at baseline and after 4 and 8 weeks of product use. For repeated measurements, eyebrow hairs in the assessment areas were trimmed, and phototrichogram analysis was performed to determine the number of eyebrow hairs per square centimeter.
Eyebrow length was evaluated from images obtained using Folliscope 5.0 at baseline and after 4 and 8 weeks. Eyebrow hair length was analyzed using Image-Pro 10 image analysis software.
Compliance was assessed using participant-completed product-use diaries. Participants also completed a questionnaire regarding their experience with the investigational product. Throughout the study, investigators monitored skin adverse reactions and the use of concomitant medications that could affect study evaluation.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Korean adults aged 20 years or older
- •Individuals who received sufficient information about the purpose and procedures of the study and voluntarily signed the informed consent form
- •Individuals without acute or chronic physical illnesses, including skin diseases
- •Individuals able to participate in follow-up assessments throughout the study period
排除标准
- •Individuals who were pregnant, breastfeeding, or planning to become pregnant
- •Individuals with a psychiatric disorder or an infectious skin disease
- •Individuals who had used a topical corticosteroid for the treatment of a skin disease for 1 month or longer
- •Individuals who had participated in the same study within the previous 6 months
- •Individuals with sensitive or hypersensitive skin
- •Individuals with abnormal skin findings at the assessment area, including moles, acne, erythema, or telangiectasia
- •Individuals who had used cosmetics, medications, or other products with the same or similar claimed effects on the assessment area within the previous 3 months
- •Individuals who had received dermatologic or cosmetic procedures on the assessment area within the previous 6 months, including liposuction, laser treatment, ultrasound-assisted fat reduction, or other skin care procedures
- •Employees of the study institution
- •Individuals considered unsuitable for study participation by the principal investigator
研究组 & 干预措施
Investigational Product-Treated Eyebrow
CosmeRNA Brow Revitalizing Serum containing SDS-DNA-2/RNA-6 was applied to the assigned eyebrow once daily for 8 weeks.
干预措施: Eyebrow serum containing SDS-DNA-2/RNA-6 (Other)
Control Product-Treated Eyebrow
The control serum formulated without SDS-DNA-2/RNA-6 was applied to the assigned eyebrow once daily for 8 weeks.
干预措施: Control eyebrow serum without SDS-DNA-2/RNA-6 (Other)
结局指标
主要结局
Change From Baseline in Eyebrow Density
时间窗: Baseline to Week 4 and Baseline to Week 8
Eyebrow density was measured as the total number of eyebrow hairs per square centimeter using phototrichogram images obtained with Folliscope 5.0. Changes from baseline were evaluated for the eyebrow treated with the investigational serum and the contralateral eyebrow treated with the control serum.
Change From Baseline in Eyebrow Hair Length
时间窗: Baseline to Week 4 and Baseline to Week 8
Eyebrow hair length was measured in pixels using Image-Pro 10 software applied to images obtained with Folliscope 5.0. Changes from baseline were evaluated for the eyebrow treated with the investigational serum and the contralateral eyebrow treated with the control serum.
次要结局
- Participant-Reported Evaluation of the Investigational Serum(Week 8)
- Incidence of Skin Adverse Reactions(From baseline through Week 8)