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IRCT20181011041311N1 IRCT 2019-03-09 Mashhad University of Medical Sciences The effectiveness of oral minoxidil in women with scalp hair loss A triple-blind randomized clinical trial on the effectiveness of oral minoxidil in the treatment of women with Androgenetic Alopecia 2018-12-22 anticipated 60 Complete https://irct.ir/trial/34949 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: blocked This method is used to prevent significant imbalances in the number of participants assigned to each group. Allocation Concealment: Sealed envelopes The method used to generate a random assignment sequence: A random number table using www.randomization.com, Blinding description: Individuals under study, evaluators and analysts will be unaware of the intervention and control groups. 3 Female pattern hair loss (FPHL) androgenic alopcia. Intervention 1: Intervention group: Daily treatment with Oral Minoxidil Tablets (0.25 mg) and topical Placebo (1 CC twice a day) for one year. Intervention 2: Control group: Daily treatment with topical minoxidil (1 cc of 2% solution twice daily) and oral placebo for one year. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Vahideh Saabeti
No B42, Kohansangi Residential Complex, Koohsangi 15 Ave, Koohsangi St
Mashhad Iran (Islamic Republic of) 9176774448 +98 51 3849 4720 sabetiv@yahoo.com Mashhad University of Medical Sciences scientific Dr sadegh Vahabi Amlashi
daneshgah st, Imam Reza hospital, Dermatology department
Mashhad Iran (Islamic Republic of) 9137913316 +98 51385430319 VahabiS@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women with female pattern hair loss androgenic alopcia ( with sinclair stgae between 2 and 5) based on clinical diagnosis and histopathology Age: between 18 and 50 18 years 50 years Female Other causes of hair loss, including inflammatory and cicatricial hair loss The presence of other symptoms of hyperandrogenism (in particular, malaise and hirsutism), which is also evident in laboratory examination of hormonal disorders supported by polycystic ovaries, ovarian and adrenal tumors. Severe systemic disease (cardiovascular - renal - hepatic) A history of pressure drop or blood pressure less than 90/60 mmHg The patient's desire for pregnancy during one year is under study Taking any effective medication for alopecia, including hormonal medications L64 Androgenic alopecia Treatment - Drugs Treatment - Drugs Intervention group: Daily treatment with Oral Minoxidil Tablets (0.25 mg) and topical Placebo (1 CC twice a day) for one year Control group: Daily treatment with topical minoxidil (1 cc of 2% solution twice daily) and oral placebo for one year Hair loss condition. Timepoint: Every 3 months. Method of measurement: based on Sinclair scale and shedding scale. Evaluating the density and thickness of the hair. Timepoint: Every 3 months. Method of measurement: By trichoscopy. Blood pressure, weight. Timepoint: Weekly up to one month then monthly up to three months and then every three months. Method of measurement: Pressure gauge cuff, Weight gauge. Liver, renal and electrolyte tests. Timepoint: The third and 12th month after starting treatment. Method of measurement: Blood sampling. Mashhad University of Medical Sciences Approved 2018-11-13 Ethics committee of Mashhad University of Medical Sciences Opposite to Daneshgah 18 St, Mashhad University of Medical Sciences, Deputy of Research and Technology of the University Mashhad Razavi Khorasan Iran (Islamic Republic of)