Frontal Fibrosing Alopecia, Lichen Planopilaris of Scalp
Conditions
Keywords
Tofacitinib, Frontal Fibrosing Alopecia Severity Index (FFASI), Frontal Fibrosing Alopecia Severity Score (FFASS), Lichen Planopilaris Activity Index (LPPAI), Frontal fibrosing alopecia, Lichen planopilaris
Brief summary
This study aims to determine the efficacy and safety of tofacitinib therapy in Thai patients with recalcitrant frontal fibrosing alopecia. The main questions are 1. Does Tofacitinib significantly reduce Frontal Fibrosing Alopecia Severity Index (FFASI), Frontal Fibrosing Alopecia Severity Score (FFASS), Lichen Planopillaris Activity Index (LPPAI) compared to baseline and after 16 weeks? 2. Is Tofacitinib significantly different for adverse events compared to baseline and after 16 weeks? Participants will have a check-up in clinical and investigation and then get prescribed oral Tofacitinib 5 mg twice a day for 12 weeks. After that, they will have follow-up every 4 weeks until week 16.
Detailed description
1.The researcher collects personal data, including age, gender, weight, height, body mass index, waist circumference, personal medical history, history of medication use in the past 3 months (menstruation history for female subjects), and records of symptoms such as hair loss history and diagnosis, pattern of hair loss on the scalp or other areas, comorbidities, family history, and other accompanying symptoms. 2\. The researchers require the patients to undergo various blood tests before treatment. 3\. The researchers collect data on the patients' skin conditions using a Digital Camera and a Dermoscope. They capture images of the scalp, eyebrows, eyelashes, facial rashes, joint folds, arms, legs, nails, mouth, and dark spots (if present). 4\. Participants in the research will receive oral Tofacitinib medication with a dosage of 5 mg twice a day for 12 weeks. They will be scheduled to come for follow-up every 4 weeks throughout the 12 weeks, and will continue to be followed up for 4 weeks after stopping the medication. The total duration of the research will be 16 weeks. The purpose is to evaluate the effectiveness and safety of the medication. 1. The disease symptoms to be assessed include facial papule, LP pigmentosus, pruritus, trichodynia, perifollicular erythema, and hyperkeratosis. 2. Frontal Fibrosing Alopecia Severity Index (FFASI) 3. Frontal Fibrosing Alopecia Severity Score (FFASS) 4. Lichen Planopillaris Activity Index (LPPAI) 5. The photograph will be taken. The areas photographed include the scalp, eyebrows, eyelashes, facial rashes, joint folds, arms, legs, nails, dark spots (if present), and mouth. Two expert physicians will evaluate the photographs independently. The photographs of 10 patients were assessed to determine the consistency among the physicians before evaluating the actual patients. The evaluation will determine whether the patient's conditions have improved, remained stable, or worsened. 6. Dermoscopy will be performed. The areas examined include the scalp, eyebrows, eyelashes, facial rashes, joint folds, arms, legs, nails, dark spots (if present), and mouth. 7. The patient's abnormal symptoms after medication administration will be evaluated, including respiratory tract infections, skin abnormalities, gastrointestinal abnormalities, urinary tract infections, or other symptoms. 8. Laboratory tests will be conducted at weeks 4, 12, and 16 to assess the medication's safety.
Interventions
DRUGTofacitinib 5 MG
Participants in the research will receive oral Tofacitinib medication with a dosage of 5 mg, twice a day, for 12 weeks. They will be scheduled to come for follow-up every 4 weeks throughout the 12-week period, and will continue to be followed up for 4 weeks after stopping the medication. The total duration of the research will be 16 weeks. The purpose is to evaluate the effectiveness and safety of the medication.
Sponsors
Institute of Dermatology, Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) | 16 weeks after taking oral Tofacitinib | The effectiveness of this study will be evaluated by comparing the Frontal Fibrosing Alopecia Severity Index (FFASI) (Max score = 100 and Min score = 0), Frontal Fibrosing Alopecia Severity Score (FFASS) (Max score = 25 and Min score = 0), and Lichen Planopilaris Activity Index (LPPAI) (Max score = 10 and Min score = 0) between week 0 (baseline week) and week 16. If a patient has a lower score on all of these indices, it means the treatment is more effective. In addition, two expert physicians will independently evaluate the photographs. The two evaluators will determine whether the patient's conditions have improved, remained stable, or worsened. |
Secondary
| Measure | Time frame |
|---|---|
| Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA) | 16 weeks after taking oral Tofacitinib |
Countries
Thailand
Participant flow
Recruitment details
Recalcitrant frontal fibrosing alopecia patients who were confirmed diagnosed. Participants were out-patients treated at the Hair and Nail Center, the Institute of Dermatology, from November 2023 to March 2024 and qualified for inclusion criteria.
Pre-assignment details
If abnormal blood test results are found during each follow-up visit, such as a 3-fold increase in liver enzymes (AST and/or ALT) from the baseline, consideration should be given to stop taking tofacitinib immediately.
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib taking oral Tofacitinib 5 mg twice a day for 12 weeks
Tofacitinib 5 MG: Participants in the research will receive oral Tofacitinib medication with a dosage of 5 mg, twice a day, for 12 weeks. They will be scheduled to come for follow-up every 4 weeks throughout the 12-week period, and will continue to be followed up for 4 weeks after stopping the medication. The total duration of the research will be 16 weeks. The purpose is to evaluate the effectiveness and safety of the medication. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Tofacitinib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Race/Ethnicity, Customized asian | 11 participants |
| Region of Enrollment Thailand | 11 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 5 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA)
The effectiveness of this study will be evaluated by comparing the Frontal Fibrosing Alopecia Severity Index (FFASI) (Max score = 100 and Min score = 0), Frontal Fibrosing Alopecia Severity Score (FFASS) (Max score = 25 and Min score = 0), and Lichen Planopilaris Activity Index (LPPAI) (Max score = 10 and Min score = 0) between week 0 (baseline week) and week 16. If a patient has a lower score on all of these indices, it means the treatment is more effective. In addition, two expert physicians will independently evaluate the photographs. The two evaluators will determine whether the patient's conditions have improved, remained stable, or worsened.
Time frame: 16 weeks after taking oral Tofacitinib
Population: The effectiveness of tofacitinib for FFA was assessed by comparing the Frontal Fibrosing Alopecia Severity Index (FFASI) (ranging from 0 to 100), Frontal Fibrosing Alopecia Severity Score (FFASS) (ranging from 0 to 25), and Lichen Planopilaris Activity Index (LPPAI) (ranging from 0 to 10) between baseline (week 0) and week 16. Lower scores across these indices indicated greater treatment effectiveness. Two independent dermatologists reviewed patient photographs to determine improvements.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) | FFASI at baseline (week 0) | 47.5 score on a scale | Standard Deviation 13.25 |
| Tofacitinib | Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) | FFASI at week 16 | 44 score on a scale | Standard Deviation 13.5 |
| Tofacitinib | Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) | FFASS at baseline (week 0) | 16.3 score on a scale | Standard Deviation 4.07 |
| Tofacitinib | Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) | FFASS at week 16 | 15.9 score on a scale | Standard Deviation 4.62 |
| Tofacitinib | Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) | LPPAI at baseline (week 0) | 1.83 score on a scale | Standard Deviation 1.01 |
| Tofacitinib | Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) | LPPAI at week 16 | 1.33 score on a scale | Standard Deviation 0.49 |
Secondary
Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA)
Time frame: 16 weeks after taking oral Tofacitinib
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib | Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA) | mild acne vulgaris | 4 participants |
| Tofacitinib | Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA) | hypercholesterolemia | 5 participants |