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IRCT20090813002342N11 IRCT 2020-10-07 Mazandaran University of Medical Sciences The effect of latanoprost for the treatment of patient with scalp patchy alopecia Evaluation of clinical efficacy of latanoprost drop 0.005% for the treatment of patients with scalp patchy alopecia 2018-06-11 anticipated 30 Complete https://irct.ir/trial/36471 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a simple randomization method, individuals who met the inclusion criteria and completed the informed consent form were assigned to two groups. The procedure was as follows: beads numbered 01 to 30 were placed in a sealed envelope. When a patient met the inclusion criteria and the exclusion criteria, a number was took out from the envelope by lottery. If the number was odd, the patient was assigned to group 1 and if it was even, the patient was assigned to group 2. The randomization process was performed by the department secretary (who was independent of the principal investigators). Randomization was performed when a patient entered the study and the intervention was assigned according to his group therapy. For allocation concealment the envelope containing the numbers was closed again and opened only to enter the next patient to draw lottery, Blinding description: The patient knew he might be in the intervention or placebo group but did not know which group he was in. The clinical evaluator and the person responsible for the statistical analysis were not aware of the patient group. All patients in the case and control groups received topical corticosteroids (clobetasol in isopropyl alcohol) twice daily, but patients in the case group also received 0.005% latanoprost drop (twice daily) and patients in the control group received placebo (twice a day). Both the drug and the placebo were prepared by the Sinadarou factory, Iran. So that the appearance of the drug dosage form and its content, apart from its active ingredient, were exactly the same. Clobetasol cream was prepared from Daroupakhsh factory, Iran. 3 Alopecia areata. Intervention 1: Intervention group: Patients in this group received latanoprost drop 0.005% at a rate of 5 drops per 3 cm2 baldness (twice daily) with clobetasol in isopropyl alcohol (twice daily). Latanoprost drop 0.005% and clobetasol cream were prepared from Sinadarou factory (Iran) and Daroupakhsh factory (Iran) respectively. Intervention 2: Control group: Patients in this group received a placebo drop of latanoprost at the rate of 5 drops per 3 cm2 of baldness (twice a day) with clobetasol in isopropyl alcohol (twice a day). Latanoprost drop placebo and clobetasol cream were prepared from Sinadarou factory (Iran) and Daroupakhsh factory (Iran) respectively. Yes - There is a plan to make this available What will be shared: All data is shareable after unidentified individuals. When: Access period starts 6 months after the results are published To whom: Researchers in academic and scientific institutions Conditions: For information on the details of the study without doing new statistical analysis Where to obtain: Sending an email to mrrafati@mazums.ac.ir How to obtain: The email will be checked if the request is clear and the information conditions are met Information is sent. Comments:
public Mohammad Reza Rafati
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd.
Sari Iran (Islamic Republic of) 4847193698 +98 11 3354 3084 mrrafati@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mohammad Reza Rafati
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd.
Sari Iran (Islamic Republic of) 4847193698 +98 11 3354 3084 mrrafati@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patient with scalp patchy alopecia Minimum age 12 years 12 years no limit Both Pregnancy Liver disease Kidney disease Diabetes Autoimmune diseases Use of immunosuppressive drugs L63 Alopecia areata Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group received latanoprost drop 0.005% at a rate of 5 drops per 3 cm2 baldness (twice daily) with clobetasol in isopropyl alcohol (twice daily). Latanoprost drop 0.005% and clobetasol cream were prepared from Sinadarou factory (Iran) and Daroupakhsh factory (Iran) respectively. Control group: Patients in this group received a placebo drop of latanoprost at the rate of 5 drops per 3 cm2 of baldness (twice a day) with clobetasol in isopropyl alcohol (twice a day). Latanoprost drop placebo and clobetasol cream were prepared from Sinadarou factory (Iran) and Daroupakhsh factory (Iran) respectively. Hair loss area. Timepoint: At the beginning of the study, the end of the first, second and third months. Method of measurement: Hair loss site photo. Mazandaran University of Medical Sciences Approved 2017-08-13 Ethics Committee of Mazandaran University of Medical Sciences College of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd. Sari Mazandaran Iran (Islamic Republic of)