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IRCT20200130046311N1 IRCT 2021-04-13 Tehran University of Medical Sciences Comparison of the effect of DiphenCiprone alone and DiphenCiprone with intralesional injection of platelet-rich plasma in alopecia areata Comparative evaluation of the response rate based on tricoscopic criteria in patients with severe alopecia areata treated with diphencyprone with or without intralesional platelet rich plasma 2020-02-29 anticipated 20 Complete https://irct.ir/trial/46086 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized block method was used to randomize treatments to the two different head area(left and right). Blocks in the size of 2 and 4 were used to generate random blocks, Blinding description: Patients participating in the study were unaware of which side of the scalp received PRP and which side the placebo. The care provider , who is also the investigator, is aware of this. People who analyze photographic images to determine SALT and dermoscopic images are unaware. The statistical consultant for data analysis is also unaware. N/A Alopecia areata. Intervention 1: Intervention group: taking Diphen Ciprone and platelet-rich plasma together. All patients participating in the study received diphen cyprone and PRP simultaneously on one side of their head (right or left randomized). Patients who respond positively to 2% diphen cyprone solution enter the next stages of treatment, starting with 0.0001% solution. After this, the patient goes to the Diphen Cypron clinic every one to two weeks and based on the patient's symptoms and the discretion of the physician, the treatment is continued with a gradual increase in the drug concentration. PRP injection is started as soon as the appropriate concentration of diphen cyprone is reached for each patient (causing mild, tolerable itching, scaling, and erythema). PRP injection is done with a one-month interval of 3 sessions. Intervention 2: Control group: Each person is his own control. This means that the opposite side of the head (right or left) is treated with topically Diphen cyprone and placebo injection. Its frequency and dose are completely in accordance with the intervention group. Yes - There is a plan to make this available What will be shared: All data can be shared When: after the end of study To whom: Researchers working in academic and scientific institutions Conditions: For research and study Where to obtain: first responsible of the study How to obtain: Send a request to responsible Comments:
public Azadeh Rezayat
Razi Dermatology Specialty Hospital, Razi Stand, Islamic Unity Square, Islamic Unity St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 azadehrezayat@gmail.com Tehran University of Medical Sciences scientific Azadeh Rezayat
Razi Dermatology Specialty Hospital, Razi Stand, Islamic Unity Square, Islamic Unity St., Tehran, Iran
tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 azadehrezayat@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) A patient with alopecia areata whose definitive diagnosis was made on clinical or histological basis and their involvement was severe (> 50% scalp area and less than 100%). Positive response to test with 2% Diphen Ciprone solution 18 years no limit Both Patients with alopecia totalis or universalis Receive any systemic treatment during the last 6 months Children under 18 years Pregnant and lactating women Immunosuppressed patient patient with platelet dysfunction patient with a history of injecting steroids on the site over the past month Fever, systemic infection and local infection at the injection site L63.8 Other alopecia areata Treatment - Other Treatment - Other Intervention group: taking Diphen Ciprone and platelet-rich plasma together. All patients participating in the study received diphen cyprone and PRP simultaneously on one side of their head (right or left randomized). Patients who respond positively to 2% diphen cyprone solution enter the next stages of treatment, starting with 0.0001% solution. After this, the patient goes to the Diphen Cypron clinic every one to two weeks and based on the patient's symptoms and the discretion of the physician, the treatment is continued with a gradual increase in the drug concentration. PRP injection is started as soon as the appropriate concentration of diphen cyprone is reached for each patient (causing mild, tolerable itching, scaling, and erythema). PRP injection is done with a one-month interval of 3 sessions. Control group: Each person is his own control. This means that the opposite side of the head (right or left) is treated with topically Diphen cyprone and placebo injection. Its frequency and dose are completely in accordance with the intervention group Severity alopecia tool score (SALT score). Timepoint: Trichoscopic evaluation at baseline, 3 months later, 6 months later. Method of measurement: Trichoscope. SALT score evaluation. Timepoint: Evaluation at baseline, 3 months later, 6 months later. Method of measurement: visual evaluation. Tehran University of Medical Sciences Approved 2019-09-20 Ethics committee of Tehran University of Medical Sciences Building No. 1 - Enghelab Ave. - Qods Street - Porsina Street - North Door of the University Tehran, Iran tehran Tehran Iran (Islamic Republic of)