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IRCT20191228045917N1 IRCT 2020-04-17 Tehran University of Medical Sciences Effect of pulse duration on laser-assisted hair removal Effect of different pulse durations on the efficacy of long-pulsed Alexandrite-assisted hair removal,A split-face comparison study 2020-06-06 anticipated 50 Complete https://irct.ir/trial/44585 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: ّFor random allocation of treatment with two different settings ( pulse duration : 3 versus 10 msec), at first, face of subject is divided to 2 parts (right and left),then we generate 50 (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 10 msec pulse duration to that side of face.It is obvious that the other side will undergo treatment with 3 msec pulse duration. For generation of random sequence , we will use an online software with this address : https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: our subjects will not know each side of their faces will be treated with which pulse duration. two dermatologists that evaluate the photographs are also blinded about the allocation of pulse durations. data analysis also will be done blindly. N/A Hirsutism. Intervention 1: intervention group: using the manufacture-recommended methods and settings, one side of the face of each patient (randomly determinded) is treated with a 10 msec pulse duration using an alexandrite laser ( Gentlase Pro. ,Candela, USA).treatment is conducted every 5 weeks for 3 sessions.hair counts and photographs are obtained before treatment and 1 month postoperatively.This laser has a wavelength of 755 nm , a wide range of pulse duration (3 -300 msec) , ability to generate fluence up to 150 J/cm2 and different spotsizes (6 to 18 mm). Intervention 2: control group: using the manufacture-recommended methods and settings, the other side of the face of each patient is treated with a 3 msec pulse duration using an alexandrite laser ( Gentlase Pro. ,Candela, USA).treatment is conducted every 5 weeks for 3 sessions.hair counts and photographs are obtained before treatment and 1 month postoperatively. 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 hirsutism.Any type of statistical analysis can be done in order to improve the treatment Where to obtain: Tehran university of medical sciences professor Pedram Nourmohamad Pour Dermatologist Razi hospital, Wahdat-e-eslami Ave., Tehran, District 12 Phone number +98 9128240659 e mail : normohamad@razi.tums.ac.ir How to obtain: information is available immediately after verifying that the applicant,s circumstances are met by the competent authorities Comments:
public Zeynab Aryanian
Razi hospital,Wahdat-e-eslami Ave.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5561 8989 z_aryanian@yahoo.com Tehran University of Medical Sciences scientific Pedram Nourmohamad pour
Razi hospital,Wahdat-e-eslami Ave.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5561 8989 normohamad@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) age 18 and above facial hirsutism with clinical diagnosis by a dermatologist 18 years no limit Female in the last 3 months has not recieved any drug for hirsutism severe photosensitivity keloidal or hypertrophic scar tendency recent sun exposure pregnancy or lactation L68.0 Hirsutism Treatment - Devices Treatment - Devices intervention group: using the manufacture-recommended methods and settings, one side of the face of each patient (randomly determinded) is treated with a 10 msec pulse duration using an alexandrite laser ( Gentlase Pro. ,Candela, USA).treatment is conducted every 5 weeks for 3 sessions.hair counts and photographs are obtained before treatment and 1 month postoperatively.This laser has a wavelength of 755 nm , a wide range of pulse duration (3 -300 msec) , ability to generate fluence up to 150 J/cm2 and different spotsizes (6 to 18 mm). control group: using the manufacture-recommended methods and settings, the other side of the face of each patient is treated with a 3 msec pulse duration using an alexandrite laser ( Gentlase Pro. ,Candela, USA).treatment is conducted every 5 weeks for 3 sessions.hair counts and photographs are obtained before treatment and 1 month postoperatively. The percentage of hair regrowth. Timepoint: at sessions 5,10,15 weeks , the percentage of hair regrowth is measured. Method of measurement: by photographic evaluation by 2 other dermatologists. Tehran University of Medical Sciences Approved 2017-01-12 Ethics committee of Tehran university of medical sciences No. 1,Poorsina Ave.,Ghods Ave.,Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)