Comparison of the effect of topical solution of Finasteride 0/2% versus topical solution of Minoxidil 5% in the treatment of Androgenic Alopecia in men, A Randomized, Double-Blind, Clinical Trial

Determining and comparing the effect of two drugs, topical solution of Finasteride 0/2% and topical solution of Minoxidil 5% in the treatment of Androgenetic Alopecia in men.

Clinical trial with control group, with parallel groups, Double blind, Random, phase 2 on 200 patients, for randomization, method alternate was used.

Patients are randomly divided into two groups of 100 people. Receive as one among bottles A and B. After daily use according to the instructions, they are monitored on a monthly basis and a checklist for each patient is completed at each visit. This process lasts up to 6 months. Monthly visit is done in the Dermatology Clinic of Imam Reza Hospital in Ardabil on sundays and wednesdays every week. During this study, neither the patient nor the attending physician was aware of the contents of the bottle prescribed to the patient and at the end of the study, after collecting and analyzing the data, the nature of bottles A and B will be determined.

If there is more than a week between medications, the patient will be excluded from the study. Patients under study during these six months should not use any other drugs (traditional and industrial), either topically or systemically because If used, they will be excluded from the study.

Patients are randomly divided into two groups of 100 people.To a group (intervention) bottle containing 25 cc of 0/2% topical Finasteride solution and the second group (control) is given 25 cc of 5% Minoxidil topical solution. Patients should be examined monthly.

The number of hairs plucked in the Pull test; Active areas for Alopecia

Change in the percentage of Finasteride (from 2% to 0.2%) due to a mistake in entering the initial information.

In this study, there will be two types of dark bottles, one named A and the other B. In one type of bottle 25 ml of Finasteride 0/2% topical solution and in the second type 25 ml of Minoxidil 5% topical solution are poured. The patients were randomly divided into two groups of 100 each and In the first stage, they are subjected to a Pull test, which is an important test to determine the active sites of Alopecia and In it 60-70 pieces of patient hair are grabbed and pulled hairs are counted and If the number of plucked hairs is more than 6-7, the test is positive and the area of ​​the head is considered as the active site for Alopecia and its subsequent monthly examination. In subsequent monthly examinations, those points on the head will be tested for loss. Then, one group is given bottle A and the other group is given bottle B. The patient should apply 15 drops of these solutions on his head every 12 hours and at the end of each month, go to the clinic for a checkup. In the monthly examination, patients also undergo a pull test and the number of hairs plucked in the test is recorded, until the end of the sixth month, which is the end of treatment. If the patient runs out of medicine during this time, he will receive a bottle with the same name as the first bottle, and if he forgets to use his medication on time, he should use his medication immediately after being reminded, but if there is a gap of more than a week between taking the drug the patient will be excluded from the study. Patients under study should not use any other drugs (traditional and industrial) during these six months, either topically or systemically as they will be excluded if the study is used, If used, they will be excluded from the study.

During this study, a dermatologist as the head of the research group in the clinic, after explaining the working method for patients and possible problems during the research period for patients, if he volunteers, he puts them in the study. In order to start treatment, they enter group A or B as one of the volunteer patients. After assigning the checklist to each patient (according to the entered group), the patient receives bottles containing the treatment solution (A or B) from the head of the clinic according to his checklist. During this process, neither the specialist physician nor the clinic manager nor the patient don't knows the contents of the therapeutic bottle and which group of bottles are Finasteride or Minoxidil. Therapeutic bottles are made by a pharmacologist in the university laboratory and poured into bottles and then transported to the clinic of the study. The pharmacologist is the only person who knows the contents of the bottles and during the study and analysis of the data has nothing to do with the dermatologist and the head of clinic and the analyzer and patients. After the end of sampling and the end of the 6-month treatment period, by analyzing the data, the analyzer presents the information in the form of an initial grouping, and at the end of the analysis, the nature of the bottles will be determined by a pharmacologist.

All data is potentially shareable after unidentified individuals.

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Amir Sadrinia Email address: sadriamir73@gmail.com

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