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IRCT20191203045592N1 IRCT 2020-01-03 Esfahan University of Medical Sciences Microneedling in androgenetic alopecia Comparative efficacy study of microneedling (2 different depth of penetration) and topical minoxidil versus topical minoxidil alone in androgenetic alopecia in patients referring to educational center of Isfahan university of medical sciences 2018-04-21 anticipated 60 Complete https://irct.ir/trial/43968 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Three experimental groups are evaluated in this study. All patients receive a topical drug with a similar dose. patients in two intervention groups receive microneedling procedure with different settings ,other than topical solution, Randomization description: Each patient will be assigned a number from 01 to 60. Then we randomly choose a spot on the random digit table. we use the first 2 digits of the numbers on the chart (since we have a population of 60 patients) and document the first 20 numbers that are less than 61. Patients with these numbers are allocated to control group. Patients with the next 20 numbers collected from the chart, are allocated to microneedling group with a depth of 1.2 mm. the rest of the patients belong to the third group( microneedling with a depth of 0.6 mm). Patients are not aware of group allocation, Blinding description: Patients in control group are treated with topical minoxidil solution alone. Patients in other two groups receive microneedling procedure other than topical minoxidil but depth of needle penetration is different between these two groups and patients are not aware of needle depth of penetration used for them. A second investigator compares pre treatment and post treatment photographs of patients and evaluates data collected from hair analysis system while he does not know which experimental group patient belongs to. N/A Androgenetic alopecia. Intervention 1: Control group: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks. Intervention 2: Intervention group no.1: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks as well as 6 sessions of microneedling procedure with a microneedle depth of 1.2 mm, at 2-weeks intervals. Intervention 3: Intervention group no.2: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks as well as 6 sessions of microneedling procedure with a microneedle depth of 0.6 mm, at 2-weeks intervals. No - There is not a plan to make this available Justification or reason for not sharing IPD is No information
public Samin Nabavinejad
No. 301,Shadab complex, Shadab Alley, Bijan Fotouhi Alley, Mohtasham kashani Street
Esfahan Iran (Islamic Republic of) 8175967622 +98 31 3131 7715 saminstrs@gmail.com Esfahan University of Medical Sciences scientific Samin Nabavinejad
No. 301,Shadab complex, Shadab Alley, Bijan Fotouhi Alley, Mohtasham kashani Street
Esfahan Iran (Islamic Republic of) 8175967622 +98 31 3131 7715 saminstrs@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with moderate to severe androgenetic alopecia Patients who have not used systemic medications that influence hair growth within the past 6 months 18 years 45 years Both Patients with other forms of alopecia, such as telogen effluvium and alopecia areata Patients with history of bleeding disorders Patients with keloidal tendency Patients with active infection at the microneedling site Patients with skin dermatosis with risk of Koebner phenomenon, such as psoriasis and lichen planus Pregnant and lactating women Patients with any major systemic disease L64 Androgenic alopecia Treatment - Drugs Treatment - Devices Treatment - Devices Control group: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks Intervention group no.1: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks as well as 6 sessions of microneedling procedure with a microneedle depth of 1.2 mm, at 2-weeks intervals Intervention group no.2: Use 1 CC of topical 5% minoxidil lotion (Pakdarou co., Tehran, Iran) applied twice daily for 12 weeks as well as 6 sessions of microneedling procedure with a microneedle depth of 0.6 mm, at 2-weeks intervals Hail count. Timepoint: At start of study and 14 weeks. Method of measurement: Scalp & Hair Polarizing HMS System (KC Technology Company; Korea). Hair thickness. Timepoint: At start of study and 14 weeks. Method of measurement: Scalp & Hair Polarizing HMS System (KC Technology Company; Korea). Patient's satisfaction score. Timepoint: At 14 weeks. Method of measurement: The standardized 7 point rating scale (–3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased). Investigator's assessment based on changes in standard photographs. Timepoint: Standard photography at base line and at 14 weeks. Method of measurement: The standardized 7 point rating scale (–3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased). Esfahan University of Medical Sciences Approved 2019-02-14 Ethics committee of Isfahan University of Medical Sciences No. 301,Shadab complex, Shadab Alley, Bijan Fotouhi Alley, Mohtasham kashani Street Isfahan Isfehan Iran (Islamic Republic of)