CTRI/2023/11/059370已完成不适用
A Proof-of-Concept, Efficacy Study of Midnight Kohl Pencil for Long Lasting Effect in Healthy Adult Human Female Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1.To evaluate the long-lasting effect of the test product
研究概览
简要总结
This is open label, single-arm, single centre, proof of concept, efficacy, clinical study of Midnight Kohl Pencil in healthy human female subjects.
The adult subjects will be instructed to visit the facility as per the below visits:
Visit 01(Day 01): Screening
Visit 02 (Day 02): Enrolment and Evaluations
Visit 3 (Day 03): End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Age: 18 to 50 years (both inclusive) old at the time of consent.
- •2.Sex: Healthy human non-pregnant/non-lactating females.
- •3.Frequent user of kajal.
- •4.Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application.
- •5.Subjects are generally in good general health as determined from recent medical history.
- •6.The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
- •7.The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
- •8.The subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •1.Subjects who are visually impaired or having underlying conditions that potentially impairs their vision.
- •2.Subject with eye makeup.
- •3.Subjects with known history of allergies or specific allergic reactions upon using ophthalmic cosmetic products.
- •4.Subjects with presenting ophthalmic conditions like dry eye, cataract, conjunctivitis etc.
- •5.Subjects who are regular users of prescription or cosmetic contact lens.
- •6.Subjects who have dark circles under their eyes.
- •7.Subjects who are reported pregnant/planning a pregnancy or lactating.
- •8.Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
- •9.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
结局指标
主要结局
1.To evaluate the long-lasting effect of the test product
时间窗: From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours
次要结局
- 4.To assess the effect of the test product in terms of product perception questionnaire(From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours)
- 1.To assess the effect of the test product for being smudge-free(from the baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours)
- 2.To assess the safety of the test product at the periocular region in terms of eye irritation, redness, itchiness, and lachrymation(From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours)
- 3.Change in photographs (Eye area)(From baseline before product application and after product application at T0 (within 15 min of application), T8 hours, and T24 hours)
研究者
研究点 (1)
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