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IRCT20191228045917N2 IRCT 2020-09-20 Iran's national ellites foundation laser and microdermabrasion in melasma Comparison of combination of Q-switch Nd:YAG laser and microdermabrasion , with Q-switch Nd:YAG laser alone in treatment of melasma 2020-10-06 anticipated 30 Complete https://irct.ir/trial/50804 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is going to be done as a split-face study.So each patient will be its own control, Randomization description: For random allocation of two types of treatment (laser with or without microdermabrasion), at first, face of subject is divided to 2 parts (right and left),then we generate 30 (number of our subjects) random samples with block randomization with considering 2 treatments and 4,6 and 8 blocks .Finally , we consider one side of face (that is chosen randomly) constant and based on random sequence generated, allocate the treatment with laser and microdermabrasion to that side of face.It is obvious that the other side will undergo treatment with laser alone. For generation of random sequence , we will use an online software with this address : https://www.sealedenvelope.com/simple-randomiser/v1/lists. N/A Melasma. Intervention 1: Intervention group:The side allocated to receive microdermabrasion prior to laser therapy , is treated with a total of 3 pass in each session at the following visits : baseline , month 1 , month 2 and month 3.After degreasing with alcohol and waiting for the skin to dry , 3 pass microdermabration is done using 6 mm head and 400 mmHg pressure to achieve mild erythema.After washing with water and drying, treatment with Q-switched Nd:YAG laser (1064 nm ) with fluences of 2.5 -6.5 J/cm² with a 4 or 6 mm spot ,using 2 laser passing will be done. Intervention 2: Control group:The other side of face is treated with Q-switched Nd:YAG laser (1064 ) with fluences of 2.5 -6.5 J/cm² with a 4 or 6 mm spot ,using 2 laser passing. Yes - There is a plan to make this available What will be shared: All patient information can be shared without naming and identifying them When: Details of the data are immediately available after publishing the results To whom: All researchers and health professionals working in academic ,scientific and medical institutions. Conditions: The data is only shared for person whose purpose is to improve the therapeutic course of Melasma Where to obtain: Niyusha clinic.Dr Parvaneh Hatami .Dermatologist.No 180,11th St.Gisha St.tehran,Iran.09123137987.p_hatami2001@yahoo.com How to obtain: Information is available immediately after verifying that the applicant's circumstances are met by the competent authorities Comments:
public Parvaneh Hatami
No 180,11th St.,Gisha St.
Tehran Iran (Islamic Republic of) 1447683378 +98 21 8824 2020 p_hatami2001@yahoo.com Tehran University of Medical Sciences scientific Parvaneh Hatami
No 180,11th St,Gisha St.
Tehran Iran (Islamic Republic of) 1447688378 +98 21 8824 2020 p_hatami2001@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) women and men older than 18 years with bilateral moderate or severe melasma clinically diagnosed by a dermatologist 18 years no limit Both pregnancy breast feeding use of any 4% hydroquinone formulation within last 3 months history of chemical peels microdermabrasion or facial laser treatment within last 9 months L81.1 Chloasma Treatment - Other Treatment - Other Intervention group:The side allocated to receive microdermabrasion prior to laser therapy , is treated with a total of 3 pass in each session at the following visits : baseline , month 1 , month 2 and month 3.After degreasing with alcohol and waiting for the skin to dry , 3 pass microdermabration is done using 6 mm head and 400 mmHg pressure to achieve mild erythema.After washing with water and drying, treatment with Q-switched Nd:YAG laser (1064 nm ) with fluences of 2.5 -6.5 J/cm² with a 4 or 6 mm spot ,using 2 laser passing will be done. Control group:The other side of face is treated with Q-switched Nd:YAG laser (1064 ) with fluences of 2.5 -6.5 J/cm² with a 4 or 6 mm spot ,using 2 laser passing. Melasma Area and Severity Index (MASI ) score ; Physician Global melasma improvement Assessment (PhGA) score ;Patient Global melasma improvement Assessment (PGA) score. Timepoint: baseline.12 week,16 week, 32 week. Method of measurement: Photographic evaluation by dermatologist- general assessment of the patient-asking from patients. Iran's national ellites foundation Approved 2016-03-13 Ethics committee of Rafsanjanuniversity of medical sciences Emam Ali Blv.Central building Rafsanjan Kerman Iran (Islamic Republic of)