IRCT2016022726780N1 IRCT 2016-05-02 Vice Chancellor for Research, Isfahan University of Medical Sciences Comparing the efficacy of low-level light laser therapy plus minoxidil 5% and minoxidil 5% alone in the treatment of androgenetic alopecia Comparing the efficacy of low-level light laser therapy plus minoxidil 5% and minoxidil 5% alone in the treatment of androgenetic alopecia 2015-12-11 anticipated 50 Complete https://irct.ir/trial/22097 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Androgenetic alopecia. Intervention 1: Intervention: 20 drops of a minoxidil topical solution 5% on the affected areas twice daily plus 20-minute sessions of low level light laser therapy (LLLT) using a laser comb (LDU 8024PN/8024BN, Germany)two-three times a week for 24 weeks. Intervention 2: Control: 20 drops of a minoxidil topical solution 5% (Pak Darou, Iran) on the affected areas twice daily.

public Samane Mozafarpoor

Hejar Jarib St.

Isfahan Iran (Islamic Republic of) +98 31 3620 2020 s_mozafarpoor@resident.mui.ac.ir Isfahan University of Medical Sciences scientific Dr Gita Faghihi

Sofeh Blv.

Isfahan Iran (Islamic Republic of) 8187698191 +98 31 3663 3061 g_faghihi@med.mui.ac.ir Skin Diseases and Leishmaniasis Research Center Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: consent to participate; absence of other causes of hair loss; types 1-4 on Fitzpatrick scale; stages 3-6 on Norwood Hamilton Scale (for male patter baldness); stages 2-3 on the Ludwig Scale for hair loss in women; no history of finasteride, antiandrogens (e.g. cyproterone, spironolactone, ketoconazole, and flutamide), topical estrogen, progesterone, tamoxifen, anabolic steroids, drugs potentially associated with hypertrichosis (e.g. cyclosporine, diazoxide, phenytoin, oral glucocorticoids, lithium, and phenothiazine during the three-month period before the study. Exclusion criteria: using the above-mentioned medicines during the study; lack of adherence to treatment protocol; hair transplant; any medical conditions leading to hair loss (e.g. HIV/AIDS, connective tissue disease, and inflammatory bowel disease); development of endocrinopathies such as PCO, ovarian and adrenal gland tumors, and hypothyroidism. 17 years 45 years Both L-64 Androgenic alopecia Treatment - Devices Treatment - Drugs Intervention: 20 drops of a minoxidil topical solution 5% on the affected areas twice daily plus 20-minute sessions of low level light laser therapy (LLLT) using a laser comb (LDU 8024PN/8024BN, Germany)two-three times a week for 24 weeks. Control: 20 drops of a minoxidil topical solution 5% (Pak Darou, Iran) on the affected areas twice daily. Hair density. Timepoint: Before the intervention, 3, 6, 9, and 12 months after the intervention. Method of measurement: Phototrichogram. Hair shaft diameter. Timepoint: Before the intervention, 3, 6, 9, and 12 months after the intervention. Method of measurement: Phototrichogram. Patient satisfaction. Timepoint: 3, 6, 9, and 12 months after the intervention. Method of measurement: Questionnaire. Hair regrowth based on patient's opinion. Timepoint: 3, 6, 9, and 12 months after the intervention. Method of measurement: Visual analog scale. Hair regrowth based on physician's opinion. Timepoint: 3, 6, 9, and 12 months after the intervention. Method of measurement: Digital image and observation. Headache. Timepoint: 3, 6, 9, and 12 months after the intervention. Method of measurement: Asking patients. Erythema. Timepoint: 3, 6, 9, and 12 months after the intervention. Method of measurement: Asking patients. Itching. Timepoint: 3, 6, 9, and 12 months after the intervention. Method of measurement: Asking patients. Hypopigmentation. Timepoint: 3, 6, 9, and 12 months after the intervention. Method of measurement: Observation and asking patients. Hyperpigmentation. Timepoint: 3, 6, 9, and 12 months after the intervention. Method of measurement: Observation and asking patients. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2015-12-09 Ethics Committe of Isfahan University of Medical Sciences Hezar Jarib St. Isfahan Iran (Islamic Republic of)