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IRCT20230326057776N1 IRCT 2023-04-01 Esfahan University of Medical Sciences Effects of Naltrexon in patients with Frontal Fibrosing Alopecia Clinical comparison between oral low dose of Naltrexon and standard medication in patients with Frontal Fibrosing Alopecia 2023-04-21 anticipated 30 Complete https://irct.ir/trial/69293 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple; Randomization unit: Personal; Randomization tools: SPSS software; All the participants receive a number from 1 to 30. Then they share between two groups of Naltrexon/standard medication by a simple randomization method with SPSS, Blinding description: Patients are randomly assigned to one of the two groups of naltrexone treatment and standard treatment, but they do not know which group they are in. The design of study are described for patients. 2-3 Frontal Fibrosing Alopecia. Intervention 1: Intervention group: Naltrexon. Intervention 2: Intervention group: Standard medication. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is a possibility that patients' privacy will be lost.
public Fatemeh Azadmanesh
Shohadaye-Sofe Ave, Al-Zahra Hospital, Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 009831202020 fatemehazadmanesh95@gmail.com Esfahan University of Medical Sciences scientific Mina Saber
Shohadaye-Sofe Ave, Al-Zahra Hospital, Isfahan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 mina.saber33@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) New patients without any other medications Active status of illness after leaving a systemic medication (at least a month) Active status of illness while the participants are using a topical medication 18 years no limit Both L66.9 Cicatricial alopecia, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Naltrexon Intervention group: Standard medication Pre-follicular scale. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using Dermoscope. Erythema. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Observiation. Interfollicular scale. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using a dermoscope. Decline in frontal and temple hair line. Timepoint: Examinations is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Using a ruler. Ceasing the progression of disease. Timepoint: Examination is done at the beginning of the study and then 2, 4 and 6 months later. Method of measurement: Frontal Fibrosing Alopecia Severity Index (FFASI). Esfahan University of Medical Sciences Approved 2022-12-29 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar-Jarib Ave, Isfahan Isfahan Isfehan Iran (Islamic Republic of)