CTRI/2024/01/061874已完成不适用
Proof-of-concept, Open-Label, Two-Arm, Parallel, In-Use Safety and Efficacy Study of test products: ‘RE-Do Beauty Eyebrow Enhancing Serum’ and ‘RE-Do Beauty Eyelash Enhancing Serum’.
V2.0 Cosmetics LLP1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年2月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. To assess changes in eyebrow growth parameters in terms of hair count, thickness, and density using CASLite Nova.
研究概览
简要总结
This is an open-label, in-use safety and efficacy study of two hair growth serums for eyebrow and eyelash.
A maximum of 32 female subjects will be recruited to ensure the completion of the study with a total of 30 subjects.
Subjects shall be instructed to visit the facility for the following scheduled visits:
1. Visit 01 (Day 01): Screening, enrolment, baseline evaluations, and commencement of treatment phase.
2. Visit 02 (Day 21): Safety and efficacy parameters evaluation.
3. Visit 03 (Day 45): End-of-study visit including safety and efficacy parameters evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •The subject is aged between 18 and 45 years (both inclusive) at the time of informed consent.
- •The subject is a non-pregnant, non-lactating, healthy adult female.
- •The subject has a self-reported negative urine pregnancy test.
- •The subject is in a good general health as determined from recent medical history.
- •The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
- •The subject has willingness and ability to adhere to study directions, participate in the study, and return for all specified visits.
- •The subject possesses the ability to comprehend and provide written informed consent for participation in the study.
- •The subject agrees not to use any medicated or prescription or other eyebrow and eyelash hair growth products or drugs other than the test product throughout the entire study duration.
- •Few subjects wearing contact lenses shall be included in the study.
- •Subjects with sensitive eyes, experiencing lachrymation or mild irritation due to exposure to topical chemicals or strong fumes, will be included in the study, aiming for an equal proportion compared to subjects with non-sensitive eyes.
排除标准
- •The subject is currently pregnant or lactating or is planning to become pregnant during the study period.
- •The subject is visually impaired or has any underlying condition that may potentially impair their vision.
- •The subject has a history of allergies or specific allergic reactions upon using ophthalmic cosmetic products.
- •The subject is presenting any ophthalmic condition including but not limited to dry eye, cataract, conjunctivitis.
- •The subject experienced stinging or discomfort of anything greater than 0 in the ophthalmic pre-evaluation done with isotonic saline solution.
- •The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment.
- •The subject suffers from any active clinically significant disease or any condition that according to the discretion of the investigator warrants exclusion from the study.
- •The subject is taking or has taken a medication which, in the judgement of the Investigator, makes the subject ineligible or places the subject at undue risk.
结局指标
主要结局
1. To assess changes in eyebrow growth parameters in terms of hair count, thickness, and density using CASLite Nova.
时间窗: On Day 1 before product application and subsequently on Days 21 and 45
2. To assess changes in eyelash growth parameters in terms of in hair length and coverage area using Image Pro software.
时间窗: On Day 1 before product application and subsequently on Days 21 and 45
次要结局
- Ophthalmic scoring evaluation by an ophthalmologist-trained evaluator and an ophthalmologist for irritation, stinging or discomfort effect, and the degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, and lachrymation.(On Day 01 (after test product application), Day 21, and Day 45)
- Local tolerability assessment by a dermatologist-trained evaluator and a dermatologist, for dermal safety scoring near the eye area before and after product application – evaluating skin irritation, redness, itchiness, and lachrymation.(On Day 01 (after test product application), Day 21, and Day 45.)
- Digital photography of the eye area, specifically inclusive of eyelashes and eyebrows, will be taken to evaluate visual changes.(On Day 01 (before and after test product application), Day 21, and Day 45.)
- Consumer perceptions about product usage, with a focus on sensorial attributes, will be assessed using a 5-point Likert scale (Appendix II).(On Day 21 and Day 45.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited
研究点 (1)
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