TofacitinibEffectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
Tofacitinib 5 MG
Lichen Planus+2
+ Skin Diseases
+ Skin and Connective Tissue Diseases
Treatment Study
Summary
Study start date: November 29, 2023
Actual date on which the first participant was enrolled.The study focuses on evaluating the effectiveness and safety of a medication called Tofacitinib for individuals suffering from Frontal Fibrosing Alopecia, a condition causing hair loss on the scalp and sometimes other areas. This specific condition can be stubborn and difficult to treat, so the study aims to find out if Tofacitinib can help improve symptoms like hair thinning and skin changes. Participants in this study include those with recalcitrant (hard-to-treat) cases of the condition, providing hope for those who have not found relief with other treatments. Participants take Tofacitinib orally at a dose of 5 mg twice daily for 12 weeks. They attend follow-up visits every 4 weeks during treatment and continue to be monitored for another 4 weeks after stopping the medication, making the total study duration 16 weeks. Researchers assess improvements in symptoms using various methods, including photography and specialized skin examinations, to ensure accurate results. Safety is also closely monitored through regular blood tests and evaluations of any side effects, such as infections or skin issues, ensuring the well-being of participants throughout the study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.11 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Thai males or females who were at least 18 years old 2. Participants who were diagnosed with frontal fibrosing alopecia The criteria for the diagnosis of frontal fibrosis alopecia are 2 major criteria or 1 major criterion plus 2 minor criteria. (Vañó-Galván et al., 2014) 3. Participants who were diagnosed with recalcitrant frontal fibrosing alopecia * The patient who fails treatment of at least one drug, such as hydroxychloroquine, and/or receives others, such as immunosuppressive drugs, pioglitazone, and retinoids. However, the symptoms of FFA still appear, such as perifollicular erythematous and/or scale, after taking treatment for more than 3 months * The patient continued taking the medicine as prescribed and coming to follow-up * The patient still has the medical record, such as a picture and dermoscopy * The patient does not need a washout time from the current medicine Exclusion Criteria: 1. Patients who were diagnosed with a disease that may relate to hair growth within six months, such as thyroid disease, iron deficiency anemia, liver disease, heart disease, neurological system disease, gastroenteritis disease, sexual disease, cancer, and psychologic disease 2. Pregnancy 3. Patients who have contraindications to take oral Tofacitinib such as severe infection, allergy to Tofacitinib, venous thromboembolism, leukopenia, severe liver disease, severe kidney failure, pneumonia, cancer 4. Patients who received strong or moderate to strong CYP3A4 agents 5. Patients who had positive on HBsAg and/or HCV
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Hair and Nail center, Institute of Dermatology
Bangkok, ThailandOpen Hair and Nail center, Institute of Dermatology in Google Maps