]>
IRCT20210130050179N9 IRCT 2024-02-25 Nano tarpak company Clinical evaluation of the safety and effectiveness of the nanofiber undereye pad to improve surface wrinkles and dark circles under the eyes Clinical evaluation of the safety and effectiveness of the nanofiber undereye pad containing ketone enzyme to improve surface wrinkles and dark circles under the eyes compared to placebo 2024-02-20 anticipated 10 Complete https://irct.ir/trial/75199 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the measurements, the lower area of the right or left eye was used for the use of nanofiber under eye pad containing the active substance ( ketone) and the opposite area as a control for using nanofiber under eye pad without the active substance. Randomization is done simply using blind card. In this way, the name of the formulations is written on the same cards and for each of the left or right area, a card is selected randomly. 2 periorbital wrinkle, dark circle and puffiness. Intervention 1: Intervention group: 30 minutes of using nanofiber under-eye pads containing ketone co-enzyme made by Nanotarpak company for 6 days. Intervention 2: Control group: 30 minutes of using a nanofiber under-eye pad without active ingredients for 6 days. 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) Street, Taleqani Avenue
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8897 2220 drtaraneh@yahoo.com Tehran University of Medical Sciences scientific Alireza Firooz
No. 415, Shahid Naderi (Soheil) Street, Taleqani Avenue
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 18-59 years Signed informed consent knowingly The presence of mild to moderate periorbital wrinkle and darkness 18 years 59 years Both Using any eye product within 2 weeks before the intervention Strict diet in the period of 2 weeks before the intervention Pregnancy or lactation Being exposed to strong sunlight during the day R23.4 Changes in skin texture Treatment - Devices Other Intervention group: 30 minutes of using nanofiber under-eye pads containing ketone co-enzyme made by Nanotarpak company for 6 days Control group: 30 minutes of using a nanofiber under-eye pad without active ingredients for 6 days Assessment of under eye dark circle and wrinkle. Timepoint: Before intervention and 6 and 28 days after treatment. Method of measurement: Based on GIAS(Global Aesthetic Improvement Scale). Melanin content. Timepoint: fore intervention and 6 and 28 days after treatment. Method of measurement: Mexameter. Infra-orbital pigmentation severity and degree of lightness. Timepoint: fore intervention and 6 and 28 days after treatment. Method of measurement: Visioface. Nano tarpak company Approved 2024-01-21 Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science Unit 1-219, 2nd floor,The Institute of Pharmaceutical Sciences, Faculty of Pharmacy,16 Azar Avenue Tehran Tehran Iran (Islamic Republic of)