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IRCT20220316054304N1 IRCT 2022-09-05 Shiraz University of Medical Sciences Effect of topical Latanoprost combined with microneedling in the treatment of alopecia areata Investigation of the efficacy of topical latanoprost 0.005% combined with microneedling in comparisson to microneedling in the treatment of the patients with scalp patchy alopecia areata 2022-09-03 anticipated 20 Complete https://irct.ir/trial/62900 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The left or right sided patches are randomly allocated by block randomization method (block sizes: 4) to receive latanoprost combined microneedling .This randomization list is prepared by Random Allocation Software. Patients will be randomly assigned into 2 groups(A or B)of 10 patients by using this computer software,which is done before the first session by a neutral colleague. Group A will receive latanoprost combined microneedling on the patches of right side of scalp and just microneedling on the patches of left side of scalp. Group B will receive latanoprost combined microneedling on the patches of left side of scalp and just microneedling on the patches of right side of scalp. (Actually each participant is case and control simultaneously.), Blinding description: this study is double-blinded.The investigator or outcome assessor (both of them is attending)is not present during doing procedures which is done by care provider.The patient is also unaware of applying latanoprost due to anesthesia induced by xyla-p. (Actually each participant is case and control simultaneously.). 3 alopecia areata. Intervention 1: Intervention side: Under aseptic precaution microneedling is performed by Dr.pen ULTIMA-A6 manufactured in USA. The device is an automated microneedling device, with 12pins cartridge. The depth of penetration will be 2 millimeters at highest speed. The device will be moving on the on right or left side of scalp patches till uniform pinpoint bleedings will be occurred on these patches.Topical eye drop latanoprost 0.005% (lataprost: Sina daroo, Tehran, Iran)will be applied on these patches by a strile swap twice ,immediately before and after performing microneedling. All of these procedures (microneedling combined with latanoprost)will be done every 2 weeks for 3 sessions. Intervention 2: Control side:Under aseptic precaution microneedling is performed by Dr.pen ULTIMA-A6 manufactured in USA. The device is an automated microneedling device, with 12pins cartridge. The depth of penetration will be 2 millimeters at highest speed. The device will be moving on opposite side of scalp patches that side have been received latanoprost combined microneedling till uniform pinpoint bleedings will be occurred on these patches.This procedure( microneedling standalone) will be done every 2 weeks for 3 sessions. 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 further information
public Maryam Sadati
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3212 5239 Msadati63@yahoo.com Shiraz University of Medical Sciences scientific Maryam Sadati
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3212 5239 Msadati63@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) age> 18 years old AA coverage <25% of scalp surface presence of 2-5 patches discontinue of intralesional triamcinolone treatment at least 2 weeks earlier stable disease without the appearance of a new patch or increase in the size of the patches for at least 15 days 18 years no limit Both allergy or hypersensitivity to any component of treatment products pregnancy or lactation any skin infection on treatment area severe medical illness simultaneous use of immunosuppressant or anticoagulant medication progressive disease posetive hair pull test L63.8 other alopecia areata Treatment - Surgery Treatment - Surgery Intervention side: Under aseptic precaution microneedling is performed by Dr.pen ULTIMA-A6 manufactured in USA. The device is an automated microneedling device, with 12pins cartridge. The depth of penetration will be 2 millimeters at highest speed. The device will be moving on the on right or left side of scalp patches till uniform pinpoint bleedings will be occurred on these patches.Topical eye drop latanoprost 0.005% (lataprost: Sina daroo, Tehran, Iran)will be applied on these patches by a strile swap twice ,immediately before and after performing microneedling. All of these procedures (microneedling combined with latanoprost)will be done every 2 weeks for 3 sessions. Control side:Under aseptic precaution microneedling is performed by Dr.pen ULTIMA-A6 manufactured in USA. The device is an automated microneedling device, with 12pins cartridge. The depth of penetration will be 2 millimeters at highest speed. The device will be moving on opposite side of scalp patches that side have been received latanoprost combined microneedling till uniform pinpoint bleedings will be occurred on these patches.This procedure( microneedling standalone) will be done every 2 weeks for 3 sessions. Terminal hair growth change. Timepoint: The patients will be assessed in 2 every 2 weeks visits for procedures, and 3 months after the first visit. Method of measurement: ‏Terminal hair growth change garde into following 6 grade:Grade 0:no change or further hair loss /Grade 1: regrowth of 1-24% terminal hair /Grade 2: regrowth of 25-49% terminal hair /Grade 3: regrowth of 50-74% terminal hair /Grade 4: regrowth of 75-99% terminal hair /Grade 5:regrowth of 100% terminal hair. Rate of patch size change. Timepoint: ‏The patients will be assessed in 2 every 2 weeks visits for procedures, and 3 months after the first visit. Method of measurement: Rate of size change (%)= Baseline size-Follow up size/Baseline size ×۱۰۰. Patient satisfaction. Timepoint: ‏The patients will be assessed in 2 every 2 weeks visits for procedures, and 3 months after the first visit. Method of measurement: A 5-point scale. 4: Extremely satisfied, 3:Very satisfied, 2: satisfied, 1: Slightly satisfied, 0: Not satisfied. Shiraz University of Medical Sciences Approved 2022-05-09 ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand St., Shiraz. Iran Shiraz Fars Iran (Islamic Republic of)