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IRCT20210130050179N3 IRCT 2022-05-17 Akhavi laboratory Efficacy comparison of 2 tinted and invisible sunscreen products with similar formulation and SPF 50, on reducing skin damage caused by sunlight Efficacy comparison of 2 tinted and invisible sunscreen products with similar formulation and SPF 50, on reducing skin damage caused by sunlight in the Iranian population with skin type 2 to 4:Single-blind randomized clinical trial 2022-05-22 anticipated 110 Complete https://irct.ir/trial/63180 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method will be used to assign samples to each of the tinted and invisible sunscreen groups. At first, the size of the blocks will be considered to be 10, according to the number of samples, 11 blocks will be selected based on a table of random numbers and individuals will be assigned to groups based on their position in the blocks, Blinding description: Due to the difference in appearance of two types of creams, the assessor person who performs the biophysical tests of the skin and the physician supervising the tests are different from who assigned the creams and therefore the study is outcome assessor blind. 3 Reduce skin damage caused by sunlight. Intervention 1: Intervention group: Tinted sunscreen cream will be used every three hours from 8 AM to 8 PM (4 times in a day). Intervention 2: Control group: Invisible sunscreen cream will be used every three hours from 8 AM to 8 PM (4 times in a day). 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 8896 0880 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) Healthy people aged between 18 to 60 years Signing the informed consent form 18 years 60 years Both History of any skin disease except acne, allergies and rosacea Facial skin surgery in the last 2 months Any systemic disease that affects the skin (diabetes, thyroid disease and etc..) L55 Sunburn Treatment - Drugs Treatment - Drugs Intervention group: Tinted sunscreen cream will be used every three hours from 8 AM to 8 PM (4 times in a day) Control group: Invisible sunscreen cream will be used every three hours from 8 AM to 8 PM (4 times in a day) Skin melanin. Timepoint: Before intervention and 8 and 16 weeks after treatment. Method of measurement: mexameter. Changes in erythema intensity (factor E) and skin lightness (factor L). Timepoint: Before intervention and 8 and 16 weeks after treatment. Method of measurement: Using Visioface device and CSI software. Akhavi laboratory Approved 2021-06-16 Ethics committee in research of medical school-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)