A prospective phase II, open label, monocentric, single arm clinical study on safety andEfficacy of the Elure advanced skin whitening products (Advanced whitening lotion andAdvanced whitening night cream) in imparting skin fairness on healthy human volunteers with Skin type III, IV and V.

Syneron P Ltd0 个研究点目标入组 40 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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•Female subjects in generally good health.
•Subject can read and comprehend with the English informed consent form.
•Subjects of skin types III, IV, and V.
•Subjects age group 18 - 60 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 post inflammatory hyperpigmentation, freckles, pigmented demarcation lines, and uneven tone skin will also be included.
•The subject will be enrolled after the sensitivity test is negative for all the sites

•A known history or present condition of allergic response to any cosmetic products.
•Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings.
•Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
•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 fairness/whitening/ brightening creams including vitamin A derivatives.
•Subjects who are pregnant, lactating or nursing.
•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.
•Subject having any sensitive reaction to the investigational product- Skin Sensitivity test.

发起方

Syneron P Ltd