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IRCT20210130050179N1 IRCT 2021-02-20 Iran Avandfar Company Safety and efficacy assessment of Synskin triple action eye contour cream Safety and efficacy assessment of Synskin triple action eye contour cream (invisible) for reducing periorbital wrinkle, dark circle and puffiness 2021-02-14 anticipated 20 Complete https://irct.ir/trial/54157 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 periorbital wrinkle, dark circle and puffiness. Intervention group: Using Synskin triple action eye contour cream twice a day for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Taraneh yazdanparast
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 drtaraneh@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Shahid Naderi (Soheil) St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 7921 firozali@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Male or female aged 30-60 years The presence of periorbital wrinkle, dark circle and puffiness No change in life style during the study Signed informed consent knowingly 30 years 60 years Both Critical untreated systemic disease in medical history Any facial rejuvenation treatment, including treatment with topical or oral products or supplements during the last four weeks Any facial rejuvenation treatment including rejuvenation devices or surgical procedures and Botox injections during the last four months Sensitivity and allergy to the components of the formulation Use of any eye cream or eye sunscreen cream during the last four weeks Use of anti-wrinkle or brightening cleansers over the past four weeks Pregnancy or lactation Treatment - Drugs Intervention group: Using Synskin triple action eye contour cream twice a day for 8 weeks Assessment of periorbital wrinkle, dark circle and puffiness by three independent physician using 0-3 scale. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Three independent dermatologists perform evaluation and scoring with the help of right and left lateral view and full face photos based on the percentage of improvement in periorbital wrinkles, dark circle and puffiness using scale 0 to 3 (0 = no improvement 1 = relative improvement 2 = good improvement 3 = Excellent improvement) . Area, volume and depth of periorbital wrinkle. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Visioface. Periorbital dark circle grading using Characteristics of Dark circles grade. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Research physician will perform clinical assessments according to the Characteristics of Dark circles grade. Melanin content. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Mexameter. Stratum corneum hydration. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Corneometer. Trans epidermal water loss. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Tewameter. Erythema. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Mexameter. Fitzpatrick’s Classification of Facial Wrinkling & degree of Elastosis. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Research physician will perform clinical assessments according to the Fitzpatrick’s Classification. Infra-orbital pigmentation severity and degree of lightness. Timepoint: Before intervention and 4 and 8 weeks after treatment. Method of measurement: Visioface. Iran Avandfar Company Approved 2021-02-04 Ethics committee of Tehran University of Medical Sciences Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)