A Phase II randomized, double blind placebo controlled study to evaluate the efficacy and safety of Under Eye Cream in healthy human volunteers

Sami labs0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male and female subjects in generally good health.
•Subjects of skin types III, IV, and V.
•Subjects age group 18 - 55 years
•Subjects willing to give a written informed consent and come for a regular follow up.
•Subject willing to abide by and comply with the study protocol.
•Subject has not participated in a similar investigation in the past four weeks.
•Subjects having mild to severe infra orbital melanosis and fine lines.
•Subjects with no history of glaucoma, any eye infection.
•Subjects who have not taken any under eye treatments for at least 14 days prior to
•Subject should be willing to abstain from spa treatments/facials during the study period.
•Subject is not pregnant (as determined by interview),and she must agree to use an active
•form of birth control (i.e, stabilized on oral contraceptives, condom and /or spermicidal foam,
•IUD, implant, or diaphragm ) for the duration of the study.

•Pregnant or nursing female (as determined by interview).
•A known history or present condition of allergic response to any cosmetic products.
•Concomitant topical therapy in under eye area that causes hypopigmentation includes Retinoids and Hydroquinone skin peels.
•Subjects taking concomitant therapy (such as oral anti oxidants, vitamin E) that might interfere with the study results.
•Subjects with dermatological disorder of face that may interfere with study evaluation.
•Subjects with history of abnormal intraocular pressure, history of glaucoma and any eye
•infection during enrolment
•Concomitant medicines, that cause hyper pigmentation, include Phenothiazines, Anti-malarials (Chloroquine), Phenytoin sodium, cytotoxic drugs, Sulphonamides.
•Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
•Subjects not willing to discontinue other topical anti ageing, anti wrinkle facial products.
•Hypersensitivity to any component of the tested products.
•History of intense sun exposure.
•Chronic illness which may influence the cutaneous state.
•Subject participating in any other cosmetic or therapeutic trial.
•Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
•Subjects who have undergone filler treatment under the eye within the past three months.

发起方

Sami labs