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IRCT20210412050942N1 IRCT 2021-05-01 Integrated Laboratory and Research Center, University of Indonesia. Efficacy of Lotion Containing Black Rice Bran (Oryza sativa L. indica) Extract as Skin Brightening Agent, a Clinical BRBCT Comparison of the Efficacy of Lotion Containing Black Rice Bran (Oryza sativa L. indica) Extract with Placebo as Skin Brightening Agent with in Healthy Asian Women 2020-01-01 anticipated 30 Complete https://irct.ir/trial/55577 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants will be given 2 types of lotions to use on right and left elbows, which are applied evenly until they are absorbed. The lotions given have been coded, namely code A-right and code-B-left. This study lasted for 2 weeks (14 days). Every day, participants have to use the lotion for 14 days, twice a day in the morning and evening, each of approximately 1 gram by first washing participants' hands which will be smeared with the lotion and wiped dry. Participants are also asked to rub code A lotion on the back of participants' right hand using the finger of participants' left hand, and apply code B lotion to the back of participants' left hand using the finger of participants' right hand. This is done to prevent lotion A and lotion from mixing. Apply using participants' fingers until all of the lotion is evenly spread and absorbed well. Participants' are prohibited from washing hands at least 1 hour after using the product. Day 14, the use of the lotion is stopped and the researchers will re-check some parameters of participants' skin's brightness level with a Mexameter tool. 1 Healthy skin condition. Intervention 1: Intervention group: one lotion containing black rice bran extract 10% is applied in one side of volunteer's volar. each application of lotion is 0,5 gram, applied in diameter 5 centimeters. Lotion is applied twice a day (every morning and evening after shower) for 14 days. the excipients of lotions are demineralized aqua, olive oil, vaseline album, dimethicone. Cetyl alcohol, isopropyl myristate, span 80, propylparaben, BHT, tween 80, methylparaben, and glycerin. They are manufactured by Brataco (Indonesia). Intervention 2: Control group: one placebo lotion were applied in the other side of volunteer's volar. each application of lotion is 0,5 gram, applied in diameter 5 centimeters. Lotion is applied twice a day (every morning and evening after shower) for 14 days. the excipients of lotions are demineralized aqua, olive oil, vaseline album, dimethicone. Cetyl alcohol, isopropyl myristate, span 80, propylparaben, BHT, tween 80, methylparaben, glycerin and colorant. They are manufactured by Brataco (Indonesia). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Afifah Kusuma Vardhani
Semanggi Hill B5 Jl. Zakaria
Depok Indonesia 16426 +62 622 74372722 afifah.felani@gmail.com University of Indonesia scientific Afifah Kusuma Vardhani
Semanggi Hill B5 Jl. Zakaria
Depok Indonesia 16426 +62 622 74372722 afifah.felani@gmail.com University of Indonesia Indonesia healthy skin condition; Asian race 18 years 25 years Female history of allergies; pregnant or breastfeeding; chronic medical history, have tattoos, scars or burns; currently using therapies such as anti-inflammatory, corticosteroids, hormonal contraceptives, or lasers; smoke, drink alcohol and use drugs, orally consume the test substance (black rice bran extract), apply and consume skin brightening agent topically or orally Treatment - Other Placebo Intervention group: one lotion containing black rice bran extract 10% is applied in one side of volunteer's volar. each application of lotion is 0,5 gram, applied in diameter 5 centimeters. Lotion is applied twice a day (every morning and evening after shower) for 14 days. the excipients of lotions are demineralized aqua, olive oil, vaseline album, dimethicone. Cetyl alcohol, isopropyl myristate, span 80, propylparaben, BHT, tween 80, methylparaben, and glycerin. They are manufactured by Brataco (Indonesia) Control group: one placebo lotion were applied in the other side of volunteer's volar. each application of lotion is 0,5 gram, applied in diameter 5 centimeters. Lotion is applied twice a day (every morning and evening after shower) for 14 days. the excipients of lotions are demineralized aqua, olive oil, vaseline album, dimethicone. Cetyl alcohol, isopropyl myristate, span 80, propylparaben, BHT, tween 80, methylparaben, glycerin and colorant. They are manufactured by Brataco (Indonesia) Melanin index. Timepoint: 2 weeks after intervention. Method of measurement: Measure skin melanin index with mexameter. Integrated Laboratory and Research Center, University of Indonesia. Approved 2019-12-09 The Ethics Committee, Faculty of Medicine, University of Indonesia Salemba Raya No 6 Jakarta Jakarta Indonesia