A Consumer Insight Study with Instrument-Based Efficacy Assessments and Ocular Irritation (Eye Instillation) Evaluation of a Hydrating Cleanser Without Active Ingredients for Removal of Sunscreen and Everyday Makeup in Healthy Adult Male and Female Participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
This is an open-label, prospective, single-centre, consumer in-sight and instrumental evaluation study designed to evaluate Hydrating Cleanser in Healthy Adult Male and Female Participants.
The study population will include 24 adult male and female participants aged 18–55 years (both inclusive). All assessments will be conducted on a single study day at baseline, pre-usage of the test product and at T0 (+20) mins post usage of the test product.
Assessments of the test product will be done as mentioned below:
· Skin Hydration Level - Corneometer® CM 825
· Skin Digital Photography Visual Appearance® – VisioFace® RD
· Overall Dry Skin - Dermatologically Scoring Scale
· Consumer perception regarding the effectiveness of test product regarding the cleansing of dirt, oil, makeup, sunscreen and pollutants through 5-point Likert Scale
The saline screening will only be performed at the first visit. There must be at least 5 minutes wait in between the saline and product application, for any saline layover effect.
10 µl of the 10% solution of the test product dissolved in the distilled water will be added to the one eye (conjunctival sac) and control product to another eye.
The subjects will then be asked to open their eyes and to rate the intensity of perceived discomfort/irritation using the Stinging/Discomfort Scale.
This score will be recorded on the case report form.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Ages 18-55 years both inclusive.
- •Males and non-pregnant/non-lactating females 3) Females with self-reported negative pregnancy test 4) Having general good health and has both eyes.
- •Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
- •Pass an eye sting evaluation using isotonic saline.
- •Willing to refrain from using any eye drops on the day of the study.
- •In general, good health as determined by the Investigator on the basis of medical history.
- •Willig and able to follow the study protocol to participate in the study.
- •Able to understand and provide written Participant’s information sheet to participate in the study.
- •Willing not to use any other marketed product on application site during the study period.
排除标准
- •Having any known allergy to test product ingredient.
- •Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
- •Participation in any similar consumer study within the past 90 days.
- •Currently using any topical medications.
- •Any exceptions to the inclusion/exclusion criteria will be considered on a case-by case basis and will be documented in the case report form.
- •Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc.).
- •Have participated in a study with the eyes as the target area within 6 weeks of the start of the study.
- •Be involved in any aspect of study administration, i.e., evaluating applying products, etc.
- •Have a history of sensitivity and/or adverse reactions to preparations intended for the eyes.
- •Currently having any eye infections or irritation.
- •The participant is having any sensitivity to eye make-up.
- •Currently have any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study.
- •Currently using any topical medications on the face or any medications intended for the eyes.
- •Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) on the days of the study.
- •Have any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results.
研究者
Dr Nayan Patel
NovoBliss Research Pvt. Ltd.