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IRCT20220223054106N1 IRCT 2022-06-18 Tehran University of Medical Sciences Evaluation of the effectiveness of Raphanus sativus in melasma Evaluation of the effectiveness of cream containing Rhaphanus sativus seed extract in treatment of women with facial melasma - A triple blind clinical trial 2022-07-23 anticipated 25 Complete https://irct.ir/trial/63000 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is designed by splite face method; This means that each patient will randomly take the medication on one side of their face and the placebo on the other side of their face, Randomization description: Block randomization, Individual randomization, using statistical software R version 4.1.1. 25 Raphanus sativus seed extract creams and 25 placebo creams will be prepared by a traditional pharmacist. In each group of the prepared creams, the number 1 to 25 will be pasted on can of each of the creams. One of the phrases "right" or "left" will be randomly selected by block randomization method using R software version 4.1.1 and written next to the number of cans of Raphanus sativus seed extract creams. Matching the cream numbers to the right or left phrases will be kept confidential by the pharmacist until the end of the data analysis. Next to the placebo box number, a phrase opposite to what was placed in the same box number will be written. Each patient will be given two cans of cream with the same numbers. The right phrase is written on one of them and the left phrase is written on the other. (One of the cans will be Raphanus sativus seed extract cream and the other will be a placebo cream.), Blinding description: Participant: Each patient will be given two cans of cream with the same numbers, that the phrase "right" is written on one and the phrase "left" on the other randomly. (One of the cans will be Raphanus sativus seed extract cream and the other will be a placebo cream.) Patients will use each of the creams according to the phrase written on the can, on the same side, without knowing which of the creams is the drug cream and which is the placebo cream. Matching the cream numbers to the right or left phrases will be kept confidential by the pharmacist until the end of the data analysis. Outcome Evaluator: Patients before the start of treatment, in the 6th and 12th week of the study will be evaluated by a dermatologist and the number of mMASI as an indicator of severity and level of melasma involvement for each species (regardless of which species Is treated with drugs and which species is treated with placebo) will be calculated and written. Data Analyzer: At the end of the study, data collected from each patient will be presented to a statistician for review and analysis; And without knowing which item was treated with the drug and which was treated with the placebo, he determines the effectiveness or ineffectiveness of the cream used on each cheek in treating patient's melasma. Finally, the statistics obtained will be matched by the researcher with the list held by the pharmacist. 3 Melasma. Intervention 1: Intervention group: Patients will use on one side of their face a cream containing Raphanus sativus seed extract based on propylene glycol and with a concentration of 25%, twice a day (morning and night), one fingertip for 12 weeks. Intervention 2: Control group: On the other side of face, patients will use the placebo cream twice a day (morning and night) at the rate of one fingertip for 12 weeks. Placebo cream will be based on propylene glycol with a concentration of 25% and a few drops of eatable color will be added to it. Also, a few drops of Raphanus sativus seed extract will be sprayed on the back of the door of cream so that the patient can smell the Raphanus sativus when he opens the cream. 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 more information.
public Fatemeh Sharifi
No. 4, BaniAsadi Alley, Foad Musavi St., Azarbaijan Ave., Salsabil Shomali.
Tehran Iran (Islamic Republic of) 1345918736 +98 21 6636 0489 f-sharifi@razi.tums.ac.ir Tehran University of Medical Sciences scientific Fatemeh Sharifi
No. 4, BaniAsadi Alley, Foad Musavi St., Azarbaijan Ave., Salsabil Shomali.
Tehran Iran (Islamic Republic of) 1345918736 +98 21 6636 0489 f.sharifi135@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Clinical diagnosis of melasma by a dermatologist (at the Center for Dermatology and Leprosy Research) Female gender Age of over 18 years Bilateral facial melasma 18 years no limit Female Pregnancy and breastfeeding Use of any topical treatment for melasma during 2 months before the start of the study Taking oral contraceptives and hormonal drugs for 4 weeks before the study Use of drugs that increase sensitivity to sunlight; Such as doxycycline, minocycline, tetracycline, ciprofloxacin, hydrochlorothiazide and sulfonamides The presence of scars, tattoos, excessive hair, or any other condition that makes the test site less likely to be evaluated L81.0 Treatment - Drugs Placebo Intervention group: Patients will use on one side of their face a cream containing Raphanus sativus seed extract based on propylene glycol and with a concentration of 25%, twice a day (morning and night), one fingertip for 12 weeks. Control group: On the other side of face, patients will use the placebo cream twice a day (morning and night) at the rate of one fingertip for 12 weeks. Placebo cream will be based on propylene glycol with a concentration of 25% and a few drops of eatable color will be added to it. Also, a few drops of Raphanus sativus seed extract will be sprayed on the back of the door of cream so that the patient can smell the Raphanus sativus when he opens the cream. MMASI = Modified Melasma Area and Severity Index. This index is generally calculated based on the following formula: MMASI = 0.3 A (f) D (f) + 0.3 A (Lm) D (Lm) + 0.3 A (Rm) D (Rm + 0.1 A (C) D (C) . Area = A, Darkness= D, lesions in the Forehead = F, Right malar = Rm, Left malar = Lm and Chin = C. Our MMASI is evaluated separately in each half of the face, calculated with the following formula: Modified MASI score = (f) 0.15A (D + H) + (m) 0.3A (D + H) + ( c) 0.05A (D + H) The calculated number varies between zero and 24 depending on the severity of the lesion, the higher the score indicates the severity of the lesion. The Area (A) is determined between zero and 6; So that: 0 = 0% - 1 = 1 to 9% - 2 = 10 to 29% - 3 = 30 to 49% - 4 = 50 to 69% - 5 = 70 to 89% - 6 = 90 to 100% Darkness (D), used to determine the maxameter at the Center for Dermatology and Leprosy Research, is rated between zero and 4; In this way: 0 = normal; 1 = very low opacity; 2 = low opacity; 3 = significant opacity; 4 = severe opacity. Homogeneity (H) is also graded between zero and 4: 0 = non-homogeneity; 1 = low homogeneity; 2 = moderate homogeneity; 3 = high homogeneity. Timepoint: At the beginning of the study (before the intervention) and 6 weeks, 12 weeks and 16 weeks after the intervention. Method of measurement: Photograph with visio face camera to evaluate the darkness of facial skin and mexameter to examine Modified Melasma Area and Severity Index. Visual Analogue Scale. Timepoint: Before the intervention, the 6th and 12th week after the intervention. Method of measurement: Scaled questionnaire from zero to 10. Self-assessment. Timepoint: 6th and 12th week after the intervention. Method of measurement: Five-point Likert Scale. Possible skin complications. Timepoint: 6th and 12th week after intervention. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Tehran University of Medical Sciences Approved 2022-02-12 Ethics committee of Tehran University of Medical Sciences Ahmadieh Health Center, Sarparast St., Taleghani St. Tehran Tehran Iran (Islamic Republic of)