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IRCT20211109053013N1 IRCT 2021-12-03 Iran University of Medical Sciences Comparison of efficacy, side effects, and patient satisfaction in patients with limited scalp areata alopecia in a multiple group study with Latanoprost, Minoxidil, and Betamethasone Comparison of efficacy, side effects, and patient satisfaction in patients with limited scalp areata alopecia in a multiple group study with Latanoprost, Minoxidil, and Betamethasone 2021-12-06 anticipated 108 Complete https://irct.ir/trial/59903 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 108 patients will be divided equally into 5 intervention groups and one control group. For randomization, the "permuted block randomization" method will be used. In this method, the randomization unit will be a block. Different scenarios of intervention groups and control groups will be designed in 18 blocks of 6. The blocks will be numbered and placed inside a container. Then the blocks would be randomly selected and the patients will be treated based on the scenario of the selected block, Blinding description: Data will be held to a dermatologist , without being informed of the patients' treatment , for assessments and analysis . 3 alopecia areata. Intervention 1: Intervention group: Latanoprost 0.005% topical eye drops alone; Apply 50 microliters (1 drop) twice daily. Intervention 2: Intervention group: topical minoxidil solution 5% alone; 1 cc twice daily. Intervention 3: Intervention group: topical eye drops Latanoprost 0.005% and topical solution minoxidil 5%; Latanoprost 50 μl (1 drop) in the morning and Minoxidil 1 cc in the afternoon. Intervention 4: Intervention group: Topical betamethasone solution 0.1 and topical minoxidil solution 5%: betamethasone 1 cc in the morning and minoxidil 1 cc in the evening. Intervention 5: Intervention group: Topical betamethasone solution 0.1 and latanoprost eye drops 0.005%: betamethasone 1 cc in the morning and latanoprost 50 μl (1 drop) in the evening. Intervention 6: Control group: Topical betamethasone 0.1 solution, 1 cc twice daily. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Nafise Yazdanian
No 30, East 24th, Azadegan Blvd, Amirabad district
Tehran Iran (Islamic Republic of) 1437683662 +98 21 6643 6277 nf.yazdanian71@gmail.com Iran University of Medical Sciences scientific Nafise Yazdanian
No 30, East 24th, Azadegan Blvd, Amirabad district
Tehran Iran (Islamic Republic of) 1437683662 +98 21 6643 6277 nf.yazdanian71@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with localized areata alopecia of beard or scalp (<3 patches) Not receiving any medication for areata alopecia for at least 1 month before the beginning of the study Signing an informed written consent no limit no limit Both Patients with extensive alopecia (> 3 patches) Patients with any systemic disorder , ophthalmic pathology, other dermatological diseases, skin atrophy, or infection at the alopecic region Patients with allergy or hypersensitivity to any component of the treatment products Pregnant and lactating women L63 Alopecia areata Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Latanoprost 0.005% topical eye drops alone; Apply 50 microliters (1 drop) twice daily. Intervention group: topical minoxidil solution 5% alone; 1 cc twice daily Intervention group: topical eye drops Latanoprost 0.005% and topical solution minoxidil 5%; Latanoprost 50 μl (1 drop) in the morning and Minoxidil 1 cc in the afternoon Intervention group: Topical betamethasone solution 0.1 and topical minoxidil solution 5%: betamethasone 1 cc in the morning and minoxidil 1 cc in the evening Intervention group: Topical betamethasone solution 0.1 and latanoprost eye drops 0.005%: betamethasone 1 cc in the morning and latanoprost 50 μl (1 drop) in the evening Control group: Topical betamethasone 0.1 solution, 1 cc twice daily The severity of alopecia was determined by the severity of alopecia tool (SALT) score before and after therapy. Scalp hair loss grading will be as below: S0=no hair loss; S1 < 25% hair loss; S2 =25–49%hair loss; S3=50–74% hair loss; S4=75–99% hair loss and S5=100% hair loss. Grades of body hair loss included: B0, nobody hair loss; B1, some body hair loss, and B2, 100% body(excluding scalp) hair loss. Timepoint: Calculation of SALT score at the beginning of the study (before the intervention) and 2 and 6 weeks after treatment begins. Method of measurement: Regrowth was calculated as [(SALT score at base line-SALTscore at follow-up)/SALT score at base line] 100 and was categorized as A0= no change or further loss, A1=1–24% regrowth, A2=25–49% regrowth, A3=50–74% regrowth, A4=75–99%regrowth and A5=100% regrowth. Patients' satisfaction of treatment. Timepoint: At the beginning of the study (before the intervention) and 2 and 6 weeks after treatment begins. Method of measurement: By using a questionnaire: (1= no response, 2=fair improvement,3=good improvement, 4=very good improvement and 5=excellent improvement). Iran University of Medical Sciences Approved 2020-08-15 Ethics committee of Iran University of Medical Sciences No.30, East 24th Ave, Azadegan Blvd, Amirabad district Tehran Tehran Iran (Islamic Republic of)