Evaluation of the effectiveness of cream containing Rhaphanus sativus seed extract in treatment of women with facial melasma - A triple blind clinical trial

Determining the effectiveness of cream containing Raphanus sativus seed extract on women with melasma

Thriple-blind clinical trial, with case and control groups, with parallel groups, randomized by block random method using R software version 4.1.1, phase 3, on 25 patients as splite face

25 patients with bilateral melasma randomly use a cream containing Raphanus sativus seed extract on one side of the face and a placebo cream on the other side. Visit of a dermatologist at the Dermatology and Leprosy Research Center, Before starting treatment, at 6 weeks and 12 weeks of study and calculate and insert the mMASI for each side of the patient's face. Data analysis by a statistician. Dermatologist and statistician won't know which side of the face was treated by drug.

Inclusion criteria: Clinical diagnosis of melasma by a dermatologist; Female gender; Age of over 18 years; Bilateral facial melasma. Criteria for not entering: Pregnancy and breastfeeding; Use any topical treatment for melasma within 2 months before the start of the study; Taking oral contraceptives and hormonal drugs during the 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.

After 25 patients with bilateral melasma are included in the study, each of them randomly use the Raphanus sativus seed cream on one side of their face and the placebo cream on the other side, a fingertip each time, twice a day.

Modified Melasma Area and Severity Index; Possible skin side effects of drugs; self-assessment; Physician consent; Recurrence rate; Visual Analogue Scale

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.)

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.