Safety and Efficacy Study of Under Eye Skin Cream in Decreasing Under Eye Dark Circles and/or Puffiness in Healthy Human Volunteers

MCaffeine0 个研究点目标入组 42 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1)Age: >=20 to <=30 years (both inclusive) at the time of consent.
•2)Sex: Non-pregnant/non-lactating females and males.
•3)Females of childbearing potential must have a negative urine pregnancy test performed on screening visit.
•4)Subjects with Mild to Moderate under eyes dark circles with/without puffiness determined by the Skin scoring on screening visit by dermatologist or dermatologist trained scorer.
•5)Subjectâ??s in general good health as determined by Investigator based on medical history.
•6)Subjects with no history of glaucoma, any eye infection.
•7)Subject with normal intraocular pressure will be included in the study.
•8)Subjects free of any obvious infection of skin as determined by Dermatologist.
•9)Subject should be willing to abstain from spa treatments/facials during the study period.
•10)Subjects must be able to understand and provide written informed consent to participate in the study.
•11)Subjects should be willing and able to follow the study protocol to participate in the study.

•1)Pregnant or planning to become pregnant during the study period.
•2)Subjects with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
•3)Subjects with any systemic illness that would impact on the subjectâ??s safety or wellbeing and/or affect the response of the skin or the interpretation of the test results at screening.
•4)Subjects taking concomitant topical therapy in under eye area that causes hypopigmentation includes Retinoids and Hydroquinone skin peels, Phenothiazines, Anti-malarials (Chloroquine), Phenytoin sodium, Cytotoxic drugs, Sulphonamides that causes hyperpigmentation, concomitant therapy (such as oral anti-oxidants, vitamin E) that might interfere with the study results.
•5)Subjects not willing to discontinue other topical anti-ageing, anti-wrinkle facial products.
•6)Participation in a similar clinical study within the previous 90 Days.
•7)Subjects have used a similar product for the last four weeks, subjects who have undergone filler treatment under the eye within the past three months and any surgical treatment previous three months or planned during the study.
•8)Any subject in the Principal Investigators opinion not considered suitable for enrollment.

发起方

MCaffeine