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IRCT20210715051895N1 IRCT 2021-09-21 Kerman University of Medical Sciences Evaluation of efficacy of combined topical Bimatoprost and Fractionated carbon dioxide laser versus Bimatoprost alone in treatment of alopecia areata Evaluation of efficacy of combined topical Bimatoprost and Fractionated carbon dioxide laser versus Bimatoprost alone in treatment of alopecia areata patients 2021-08-23 anticipated 20 Complete https://irct.ir/trial/57928 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done using the random number table method. The table consists of numbers from one to one hundred and without a specific pattern or order and is made completely randomly. Then the numbers are touched randomly with their eyes closed. If the number is even, the treatment with bimatoprost is performed alone and if the number is odd, the combined treatment of carbon dioxide laser with bimatoprost is performed. 2 Alopecia areata. Intervention 1: Intervention group: Combination therapy with CO2 laser and topical bimatoprost.03%. How to use: Fractional CO2 laser treatment is performed once every two weeks for three months and immediately after the laser and also between laser sessions, the patient will use 0.03% topical bimatoprost twice a day. For CO2 laser, local anesthesia (EMLA cream) is performed with a closed dressing for one hour before the laser and then the desired area is sterilized with 70 ° alcohol and a fractional CO2 laser with the following settings is used: DEKA;Italy;fractional scanning mode;one pulse;spot size=15mm;power=5w;dwell time=500ms;smart stack=3;spacing=700microm;density8.7%;fluence=4.68j/cm2;energy=51.6mj . The patient will receive topical bimatoprost .03% (EXCILIA .03% 3ml sterile solution, IRAN, INOCLON) twice a day, with a cotton applicator in the area of alopecia patch for three months. Intervention 2: Control group: The patient will receive topical bimatoprost .03% (EXCILIA .03% 3ml sterile solution, IRAN, INOCLON) twice a day, with a cotton applicator in the area of alopecia patch for three months. Yes - There is a plan to make this available What will be shared: Primary and secondary outcome information is available When: Access starts five years after the results are published To whom: Academic researchers Conditions: After reviewing and approving the application by the researchers of this study, information will be available Where to obtain: E-mail Alireza Safari safarialireza111@gmail.com How to obtain: Examination of the application by the study researchers will be a maximum of two months process Comments:
public Simin Shamsimeymandi
Afzalipour Hospital, Imam Khomeyni Ave; Kerman
Kerman Iran (Islamic Republic of) 761691391 +98 34 3132 8328 meymandi_s@hotmail.com Kerman University of Medical Sciences scientific Simin Shamsimeymandi
Afzalipour Hospital, Imam Khomeyni Ave; Kerman
Kerman Iran (Islamic Republic of) 761691391 +98 34 3132 8328 meymandi_s@hotmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Alopecia areata patients who have two similar alopecia patches on the scalp 18 years no limit Both pregnancy lactation history of allergy to prostaglandin analouge Taking medication or treatment for the past three months that affects the hair cycle Uncontrolled systemic disease Non-patchy alopecia areata and involving area other than the scalp photosensivity L63 Alopecia areata Treatment - Drugs Treatment - Drugs Intervention group: Combination therapy with CO2 laser and topical bimatoprost.03%. How to use: Fractional CO2 laser treatment is performed once every two weeks for three months and immediately after the laser and also between laser sessions, the patient will use 0.03% topical bimatoprost twice a day. For CO2 laser, local anesthesia (EMLA cream) is performed with a closed dressing for one hour before the laser and then the desired area is sterilized with 70 ° alcohol and a fractional CO2 laser with the following settings is used: DEKA;Italy;fractional scanning mode;one pulse;spot size=15mm;power=5w;dwell time=500ms;smart stack=3;spacing=700microm;density8.7%;fluence=4.68j/cm2;energy=51.6mj . The patient will receive topical bimatoprost .03% (EXCILIA .03% 3ml sterile solution, IRAN, INOCLON) twice a day, with a cotton applicator in the area of alopecia patch for three months. Control group: The patient will receive topical bimatoprost .03% (EXCILIA .03% 3ml sterile solution, IRAN, INOCLON) twice a day, with a cotton applicator in the area of alopecia patch for three months. Alopecia patch area. Timepoint: at base line ,4,8,12,24 weeks later. Method of measurement: Measurement of hair regrowth rate by physical examination based on Salt score scale. Patient satisfaction. Timepoint: 4,8,12,24 weeks later. Method of measurement: By 7point global-assessment patient satisfaction questionnaire. Erythema. Timepoint: 4,8,12 Weeks from the beginning of treatment. Method of measurement: By clinical examination and classification of severity of complications into mild, moderate and severe. Scaling. Timepoint: 4,8,12 Weeks from the beginning of treatment. Method of measurement: By clinical examination and classification of severity of complications into mild, moderate and severe. Skin dryness. Timepoint: 4,8,12 Weeks from the beginning of treatment. Method of measurement: By clinical examination and classification of severity of complications into mild, moderate and severe. Pruritis. Timepoint: 4,8,12 Weeks from the beginning of treatment. Method of measurement: By clinical examination and classification of severity of complications into mild, moderate and severe. Kerman University of Medical Sciences Approved 2021-05-30 Ethics committee of Kerman University of Medical Sciences Ebne Sina Ave; Tahmasb Abad Blvd. Kerman Kerman Iran (Islamic Republic of)