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IRCT20200314046767N1 IRCT 2020-03-25 Esfahan University of Medical Sciences Comparison of the effect of topical and oral isotretinoin in treatment of frontal fibrosing alopecia Comparison of topical and oral isotretinoin in treatment of facial papules in the frontal fibrosing alopecia patients 2019-12-19 anticipated 22 Complete https://irct.ir/trial/46586 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who met the inclusion criteria will randomly divided into two groups using random allocation software, this software creates a random sequence by blocking method. Each patient participating in the study will receive a unique code, and the person performing the randomization with the software will not be informed of any further actions and interventions. After assigning the code the patients will be divided into two groups then the first group received oral form and the second group received topical form of isotretinoin. 3 Frontal fibrosing alopecia. Intervention 1: The first intervention group will receive 20 mg oral isotretinoin daily in the form of 20 mg capsules(made by pharmaceutical Zahravi Co.) with lunch meal for 3 months. Intervention 2: The second intervention group will receive topical isotretinoin in the form of 0.05% gels(made by pharmaceutical Raha Co.) in the amount of o.5 fingertip every night for 3 months. Yes - There is a plan to make this available What will be shared: The primary outcome data will be shared When: En Start the access period is 6 months after publishing the results To whom: Academic researchers Conditions: The request can be made by e-mail to the corresponding author Where to obtain: It can be done by e-mail to m.bahraminejad@yahoo.com How to obtain: Once the applicant has provided details of their ongoing project within one month from the time of application data will be available. Comments:
public Mahsa Bahraminejad
Soffe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 m.bahraminejad@yahoo.com Esfahan University of Medical Sciences scientific Mahsa Bahraminejad
Soffe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 m.bahraminejad@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with facial papules diagnosed on the basis of clinicopathological evidence. (Evidence of inflammation and fibrosis seen in papules). no limit no limit Both Pregnant or intended to be pregnant patients Lactating patients Patients with a history of allergy to retinoid compounds Known liver or kidney disease or abnormalities in related blood tests (leukopenia, moderate to severe hypercholesterolemia, hypertriglyceridemia, hypothyroidism, liver and kidney dysfunction) Patients with a history of pseudotumor cerebri Patients with a history of suicidal ideation Patients taking drugs that interact with isotretinoin L66.8 Other cicatricial alopecia Treatment - Drugs Treatment - Drugs The first intervention group will receive 20 mg oral isotretinoin daily in the form of 20 mg capsules(made by pharmaceutical Zahravi Co.) with lunch meal for 3 months. The second intervention group will receive topical isotretinoin in the form of 0.05% gels(made by pharmaceutical Raha Co.) in the amount of o.5 fingertip every night for 3 months. Recovery score based on Global Aesthetic Improvement Scale. Timepoint: Before the start of the study and 1 , 2 , 3 months after the start of treatment. Method of measurement: Grading the scale of global aesthetics based on observation. Esfahan University of Medical Sciences Approved 2019-12-18 Ethics committee of Isfahan University of Medical Sciences Soffeh Blvd Isfahan Isfehan Iran (Islamic Republic of)