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IRCT20200811048371N1 IRCT 2020-11-17 Esfahan University of Medical Sciences Assessment of the effects of combination of topical minoxidil, biotin in comparison with topical minoxidil on mild to moderate androgenetic alopecia patients referring to dermatological clinics of Alzahra hospita Assessment of the effects of combination of topical minoxidil, biotin in comparison with topical minoxidil on mild to moderate androgenetic alopecia patients referring to dermatological clinics of Alzahra hospital 2020-07-15 anticipated 40 Complete https://irct.ir/trial/50386 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients in whom the inclusion criteria apply are unlikely and easy to enter the study and the treatment is assigned to the two groups randomly with the help of online randomization. The first group of patients treated with topical minoxidil alone and the other group of patients receiving a combination of minoxidil and biotin. How to blind: Drugs in the same boxes with the same volume are given to a nurse outside the group and are coded in A and B, and the patient and the evaluating physician are unaware of the type of codes. The data is analyzed in the form of coding, so the analyst is unaware of their allocation, Blinding description: The medicines are given to an out-of-group nurse in the same boxes with the same volume and are coded in A and B forms, and the patient and the evaluating physician are unaware of the type of codes. The data is analyzed in the form of coding, so the analyst is unaware of their allocation. 3 Androgenetic alopecia. Intervention 1: Intervention group: The combination of minoxidil and biotin in a cc twice a day, due to the fact that minoxidil is dissolved in an alcoholic solvent and biotin in an aqueous solvent, to make a solvent system of 60% alcohol, 10% propylene glycol, 1% lactic acid and approximately 30% water is used. Minoxidil 5% at a rate of 1 ml and biotin at 5 mg / dl at a rate of 2 ml. Intervention 2: Control group: Using topical minoxidil as one cc twice a day, 60% alcohol, 10% propylene glycol, 1% lactic acid and approximately 30% water are used to make the solvent system.Minoxidil 5% is used in the amount of 1 ml. 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 Mokhtari
Isfahan Uiversity of Medical Sciences, Hezarjarib Blvd., Isfahan
Esfahan Iran (Islamic Republic of) 7346181746 +98 31 3629 4542 f_mokhtari2004@yahoo.com Esfahan University of Medical Sciences scientific Fatemeh Mokhtari
Isfahan Uiversity of Medical Sciences, Hezarjarib Blvd., Isfahan
Esfahan Iran (Islamic Republic of) 7346181746 +98 31 3629 4542 f_mokhtari2004@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with androgenetic alopecia Patients who have not been treated with finasteride or other anti-androgen therapy for the past 6 months 18 years 45 years Both Patients with other types of alopecia (such as alopecia areata, telogen effluvium, anagen effluvium, and scarring alopecia) Receiving systemic treatment for androgenetic alopecia during the last 6 months History of allergy to minoxidil, biotin L64.9 Androgenic alopecia, unspecified Treatment - Drugs Treatment - Drugs Intervention group: The combination of minoxidil and biotin in a cc twice a day, due to the fact that minoxidil is dissolved in an alcoholic solvent and biotin in an aqueous solvent, to make a solvent system of 60% alcohol, 10% propylene glycol, 1% lactic acid and approximately 30% water is used. Minoxidil 5% at a rate of 1 ml and biotin at 5 mg / dl at a rate of 2 ml. Control group: Using topical minoxidil as one cc twice a day, 60% alcohol, 10% propylene glycol, 1% lactic acid and approximately 30% water are used to make the solvent system.Minoxidil 5% is used in the amount of 1 ml. Standard photographic score (reported by physician). Timepoint: The effect of these two classes of drugs is measured at the end of week 24. Method of measurement: Physician evaluation of hair regrowth at the end of week 24: In this method, a physician who is blind to the study by comparing pre- and post-treatment photographs (taken by Standardized global photography in 4 views) according to a 7- point scale gives points (14). Given that all patients are examined by a physician, the probability of error in subjective assessment is low.Greatly decreased = -3Moderately decreased = -2Slightly decreased = -1No change = 0Slightly increased = +1Moderately increased = +2Greatly increased = +3. Hair regrowth score from patients' point of view. Timepoint: The effect of these two classes of drugs is measured at the end of week 24. Method of measurement: Evaluate the patient for hair regrowth at the end of week 24: In this method, the patient scores according to a 7-point scale: Greatly decreased = -3Moderately decreased = -2Slightly decreased = -1No change = 0Slightly increased = + 1Moderately increased = + 2Greatly increased = +3. Number of hair. Timepoint: The effect of these two classes of drugs is measured at the end of week 24. Method of measurement: Hair count at the end of week 24 and comparison with the number of hairs at the beginning of the study: The results will be obtained through the hair polarizer (KC Technology). Esfahan University of Medical Sciences Approved 2020-07-30 Ethics committee of Esfahan University of Medical Science Isfahan Universiy of Medical sciences, Hezarjarib Blvd. Esfahan Isfehan Iran (Islamic Republic of)