Alopecia (capitis) totalis
Conditions
Interventions
This is a randomized, controlled, double-blind (patients and principal investigator), parallel, single-center clinical study with a 24-week longitudinal follow-up of 70 patients in total. Patients wil
and group 2: baricitinib 4 mg once daily and placebo twice daily. Computerized randomization, performed by an individual not involved in patient recruitment and follow-up, will allocate 35 participant
the guarantee of confidentiality and privacy regarding the confidential data involved, reimbursement of transportation expenses, and your right to seek compensation for any damages resulting from the
Sponsors
Empresa Brasileira de Serviços Hospitalares - EBSERH
Hospital das Clínicas da Universidade Federal de Goiás
Eligibility
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients of both sexes. Minimum age of 12 years. Patients with alopecia areata with a Severity of Alopecia Areata Tool - SALT score greater than or equal to 20 and a current episode lasting at least 6 months to a maximum of 10 years. Who have informed and agreed to participate in the study, or whose legal guardians agree to participate, during treatment at the trichoses outpatient clinic of the Dermatology Service of the Federal University of Goiás -UFG or in the private practice of the principal investigator. Patients who have previously received topical corticosteroids must be off the medication for one week. Users of oral and/or intralesional corticosteroids must be off the medication for at least two months. Patients who have previously used methotrexate or Janus kinase - JAK inhibitors must be off the medication for at least eight weeks to participate in the study
Exclusion criteria
Exclusion criteria: Patients with hypersensitivity (allergy) to any of the drugs (Baricitinib or Minoxidil). Serious active infections (such as HIV and hepatitis). Clinically important active, recurrent or chronic infection. Active tuberculosis. Severe neutropenia (less than 1000). Severe lymphopenia (less than 500). Anemia (hemoglobin less than 8g/dl). Cancer patients. History of deep vein thrombosis or pulmonary thromboembolism. Patients with an increased risk of intestinal perforation (with diverticular disease). Pregnant women. Breastfeeding women. Heart disease. Kidney disease. Liver disease. Patients with pheochromocytoma. Carriers of other causes of hair loss (folliculitis decalvans, folliculitis dissecans, lichen planopilaris and its variants, frontal fibrosing alopecia) or scalp dermatoses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The goal is to achieve a Severity of Alopecia Areata Tool - SALT score of 20 or less: using a comparative photographic assessment method with standardized photos from the beginning of treatment, and after 12 and 24 weeks. The standardized photos will be evaluated by a panel of three dermatologists blinded to the treatment. The panel will calculate the SALT score from the initial photo, and after 12 and 24 weeks. We will observe the primary outcome in participants who achieve a SALT score of 20, regardless of the initial SALT score. | — |
Secondary
| Measure | Time frame |
|---|---|
| A 30% improvement in the patient's initial Severity of Alopecia Areata Tool (SALT) is expected: using a comparative photographic assessment method with standardized photos from the beginning of treatment, and after 12 and 24 weeks. The standardized photos will be evaluated by a panel of three dermatologists blinded to the treatment. The panel will calculate the SALT from the initial photo, and after 12 and 24 weeks. We will observe the secondary outcome in participants who achieve a 30% improvement in their initial SALT. ;The goal is to achieve a Severity of Alopecia Areata Tool (SALT) score of 10 or less: using a comparative photographic assessment method with standardized photos taken at baseline, and after 12 and 24 weeks. The standardized photos will be evaluated by a panel of three dermatologists blinded to the treatment. The panel will calculate the SALT score from the baseline photo, and after 12 and 24 weeks. We will observe the secondary outcome in participants who achieve a SALT score of 10 or less, regardless of their baseline SALT score.;It is expected that a variation in the specific quality of life score will be found: using the method of completing the Alopecia Areata quality of life questionnaire applied in weeks 0, 12, and 24, summing the score values ??in each week evaluated. We will observe the secondary outcome in participants who show an improvement in their quality of life questionnaire score at the end of week 24. | — |
Countries
Brazil
Contacts
Public ContactLorena Alves
Hospital das Clínicas da Universidade Federal de Goiás
Outcome results
None listed