A monocentric, single arm, open-label prospective clinical study to assess the long-lasting efficacy of The Body Shop Eye Define Kajal Bold Black in healthy adult human female participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- long-lasting efficacy of The Body Shop Eye Define Kajal Bold Black
研究概览
简要总结
A monocentric, open-label, single arm prospective clinical study. Twenty-five adult female participants in the age group of 18 years to 45 years with nearly equal representation of all skin types will be selected according to inclusion and exclusion criteria and Frequent Contact lens users and non-contact lens users (approximately in equal ratio). Dermatological, Ophthalmological and Participant Self assessments will be performed at specified time points. The allocated The Body Shop Eye Define Kajal Bold Black will be applied on the participant’s test sites (Eyes and surrounding area). The Long Lasting efficacy of the product will be evaluated.
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
- •Participant in generally good health Participant between the age group of 18 and 45 years Participant has not participated in a similar clinical investigation in the past four weeks Participant willing to abstain from using any product besides the provided product during the entire study course v.
- •Participant is a frequent user of makeup products Participant is non-user of Contact Lenses/ Frequent user of Contact Lenses Participant willing to comply with study specific requirements Participant willing to give a written informed consent and come for regular observation.
排除标准
- •Participant is having a history of allergy of or hypersensitivity to any eye cosmetics kajal eyeliner ingredients or any ophthalmic products Presence of active or recent eye infections e g conjunctivitis blepharitis Any skin condition affecting the eyelids or surrounding area e g eczema dermatitis psoriasis Participant under any dermatological treatment / prescribed medications.
- •Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month Participant viewed by the Dermat as not being able to complete the study or participating in another study Participant is Pregnant or Lactating Participant with any significant medical condition that would interfere with the participation in the trial.
结局指标
主要结局
long-lasting efficacy of The Body Shop Eye Define Kajal Bold Black
时间窗: 0 hrs 2 hr 6 hrs 24 hrs
次要结局
- Safety and tolerability of investigational product(0 hrs 2 hr 6 hrs 24 hrs)
研究者
Dr Karishma Kapoor
Auriga Research Private Limited