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IRCT20210404050843N1 IRCT 2021-05-14 Esfahan University of Medical Sciences Effect of cryotherapy and oral antihistamine in treatment of Alopesia Areata Comparison of the effect of topical betamethasone, topical betamethasone with cryotherapy, topical betamethasone with cryotherapy and oral antihistamines on hair regrowth in alopecia areata patients 2021-05-22 anticipated 48 Complete https://irct.ir/trial/55379 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Three sets of 16 cards with the letters A, B and C written on them are prepared and placed in the bag, and each patient picks a card from the bag and their group is identified. 3 Alopecia Areata. Intervention 1: Intervention group1: Treatment with betamethasone lotion 0.1%(made by Iran Najo company) daily for 12 weeks.The patient applies one to two drops of the drug (depending on the size of the bald area) once daily. This is repeated every day for 12 weeks. Intervention 2: Intervention group 2: Treatment with betamethasone lotion 0.1%(made by Iran Najo company) daily for 12 weeks, similar to the first intervention group, and cryotherapy for a maximum of six sessions, every two weeks, for eight to ten seconds. Cryotherapy is done by liquid nitrogen available in dermatology clinic, with The cotton swab is held on the hair loss area for eight to ten seconds. Cryotherapy is repeated every two weeks until the desired result is achieved, but if no response is seen after six sessions, this treatment is discontinued. Intervention 3: Intervention group 3: Treatment with betamethasone lotion 0.1% (made by Iran Najo Company) daily for 12 weeks and cryotherapy for a maximum of six sessions every two weeks once each time eight to ten seconds similar to the second intervention group with des loratadine tablets 5 mg daily for 12 weeks. Des loratadine tablets made by Abidi Pharmaceutical Company. 90 units are prescribed for patients in this group. Yes - There is a plan to make this available What will be shared: At the end of the study, study protocol, statistical analysis and clinical study report,the informed consent form, the codes used in the data analysis and the data dictionary can be shared with other researchers. When: Access period starts one month after the results are published To whom: Data will be available to researchers working in academic and scientific centers Conditions: Researchers can use the findings and data of this study in their research by submitting a document that proves their employment in scientific and academic centers. Where to obtain: Researchers can receive study data via sending an E-mail to researcher E-mail:marziehmusavi@gmail.com phone number: 09134610431 Dr Marzieh sadat Mousavi address:No1, Adl St, Mirzataher Ave, Isfahan, Iran How to obtain: Researchers can send an email to the address to indicate the type of data they need, and after reviewing their request, the information will be sent to them via email. Comments:
public Marzieh Sadat Mousavi
No.1, Adl St, Mirzataher Blvd
Isfahan Iran (Islamic Republic of) 8185793741 +98 31 3772 0390 marziehmusavi1994@gmail.com Esfahan University of Medical Sciences scientific Marzieh Sadat Mousavi
No.1, Adl St, Mirzataher Blvd
Isfahan Iran (Islamic Republic of) 8185793741 +98 31 3772 0390 marziehmusavi1994@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) patient age above 12 years Do not take another tratment for alopecia areata for at least one month before enrollment in this trial Maximum of three hair loss patches in the scalp or beard area, each of which is a maximum of 3 by 3 cm. No nail involvement related to alopecia areata 12 years no limit Both Renal or liver dysfunction Patients with a history of allergy to antihistamines Pregnancy or Lactation Lack of patient cooperation to complete the treatment process Cold intolerance Cryoglobulinemia History of cold urticaria L63 Alopecia areata Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: Treatment with betamethasone lotion 0.1%(made by Iran Najo company) daily for 12 weeks.The patient applies one to two drops of the drug (depending on the size of the bald area) once daily. This is repeated every day for 12 weeks. Intervention group 2: Treatment with betamethasone lotion 0.1%(made by Iran Najo company) daily for 12 weeks, similar to the first intervention group, and cryotherapy for a maximum of six sessions, every two weeks, for eight to ten seconds. Cryotherapy is done by liquid nitrogen available in dermatology clinic, with The cotton swab is held on the hair loss area for eight to ten seconds. Cryotherapy is repeated every two weeks until the desired result is achieved, but if no response is seen after six sessions, this treatment is discontinued. Intervention group 3: Treatment with betamethasone lotion 0.1% (made by Iran Najo Company) daily for 12 weeks and cryotherapy for a maximum of six sessions every two weeks once each time eight to ten seconds similar to the second intervention group with des loratadine tablets 5 mg daily for 12 weeks. Des loratadine tablets made by Abidi Pharmaceutical Company. 90 units are prescribed for patients in this group. Terminal hair regrowth percent. Timepoint: Before the intervention (at the beginning of the study )and three months after the last treatment session. Method of measurement: The evaluation is performed by the physician with the help of a questionnaire and based on the following scale:: Good response (more than 75% of terminal hair regrowth). Moderate response (between 50 and 75% of terminal hair regrowth). Poor response (between 25 to 50% of terminal hair regrowth) No response (less than 25% of terminal hair regrowth). Patient satisfaction. Timepoint: Before the intervention (at the beginning of the study) and three months after the last treatment session. Method of measurement: Patient satisfaction rate by the questionnaire based on numerical selection from one to ten (0= no effect, 1,2= minor effect, 3,4= moderate effect, 5,6= good effect, 9,10= very good effect). Esfahan University of Medical Sciences Approved 2021-03-20 Ethics committee of Isfahan University of Medical Sciences No 4, Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences, Hezar Jerib Blvd Isfahan Isfehan Iran (Islamic Republic of)