Clinical trial NCT06202560
Conditions: Frontal Fibrosing Alopecia Lichen Planopilaris of Scalp
Keywords: Tofacitinib Frontal Fibrosing Alopecia Severity Index (FFASI) Frontal Fibrosing Alopecia Severity Score (FFASS) Lichen Planopilaris Activity Index (LPPAI) Frontal fibrosing alopecia Lichen planopilaris
Sponsor: Institute of Dermatology, Thailand
Start date: 2023-11-29; Completion date: 2024-07-10
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: taking oral Tofacitinib 5 mg twice a day for 12 weeks
Interventions: intervention 1: Tofacitinib 5 MG
Intervention descriptions: intervention 1: 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.

Protocol documents:
Prot_SAP_000.pdf: 
 
Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : 
A Pilot Study 
 
NCT06202560 
 
Document date : 10 November 2023 
 
 


 
Introduction  
 
Frontal fibrosing alopecia (FFA) was first described in 1994 and predominantly affects 
women aged 50–60 years. It can be observed in up to 13% of women of reproductive age and 4% 
of men of color. Among women of reproductive age, FFA is more prevalent in black ethnic groups 
compared to Caucasian women. Clinically, patients with FFA typically present with symmetrical 
bandlike hairline recession in the frontotemporal region, often accompanied by scaling and redness 
around the hair follicles. FFA manifests in three patterns: linear, diffuse, and pseudo-"fringe 
signs." Hairline recession can progress to involve the posterior ear hairline and occipital area. 
Moreover, prolonged sun exposure can lead to lighter and glossier skin in the affected area 
compared to normal skin. The presence of “lonely hairs sign”, where terminal hairs remain in the 
original 3–7 cm hairline, is a characteristic diagnostic clue found in over 50% of FFA cases. 
Currently, there are no standardized guidelines for treating FFA. Treatment options include 5-
alpha reductase inhibitors, corticosteroids (oral and topical), hydroxychloroquine, isotretinoin, 
antibiotics, pioglitazone, and JAK inhibitors. These treatments yield variable outcomes, with no 
definitive information on the effectiveness of individual drugs. Systemic treatments generally aim 
to slow disease progression. JAK inhibitors are believed to reduce interferon-gamma and 
interleukin 15, thereby suppressing white blood cell activity in FFA remains unstudied in Thailand 
and inhibiting hair follicle growth. However, the use of tofacitinib in FFA has not yet been studied 
in Thailand. High treatment costs, including travel expenses and time constraints, may limit patient 
access. Further research is necessary to evaluate the effectiveness and safety of tofacitinib in 
treating FFA and to determine its potential benefits for patients with this challenging condition. 
 
Objective 
 
 
The objective is to study the effectiveness and safety of oral tofacitinib in treating 
recalcitrant FFA. 
 
Research Methodology 
 
 
The research procedure involved a pilot single-arm before-and-after clinical trial at the 
Institute of Dermatology in Bangkok, Thailand. The study protocol was approved by the 
Institutional Review Board, Institute of Dermatology, Bangkok, Thailand. 
 
Population of study  
 
Our study focused on patients diagnosed with recalcitrant FFA who were treated at The 
Hair and Nails Center, Institute of Dermatology, between November 2023 and March 2024. The 


aim was to assess the effectiveness and safety of treatment through a pilot study as no prior studies 
conducted in Thailand, with only case series published worldwide.  
Inclusion criteria included Thai individuals aged 18 or older diagnosed with FFA, who had 
failed treatment with at least one drug for more than three months, maintained medication 
adherence, and possessed relevant medical records. Exclusion criteria involved recent diagnoses 
of hair growth-affecting conditions, pregnancy, contraindications to oral tofacitinib, recent use of 
strong CYP3A4 medications, and positive tests for Hepatitis B and C.  
Research procedure 
Eleven eligible patients with recalcitrant FFA, who had been on at least one systemic 
medication for a minimum of six months, were enrolled based on inclusion and exclusion criteria. 
Demographic information, including disease duration, medical and medication history, symptoms, 
diagnoses, type of FFA, comorbidities, and family history, was collected from each patient. 
Baseline laboratory tests were performed, encompassing Complete Blood Count (CBC), liver 
function tests, lipid profile, fasting blood sugar, renal function tests, hepatitis B and C screening, 
chest X-ray, and urine pregnancy tests for women of reproductive age. Photography and 
dermoscopy were utilized for comprehensive evaluation.  
Patients received oral tofacitinib 5 mg twice daily for 12 weeks, with scheduled follow-up 
visits and assessments conducted throughout the treatment and post-treatment phases, totaling 16 
weeks. The effectiveness of treatment was evaluated using various assessments and evaluations, 
culminating in data collection and statistical analysis at the end of the study. 
Evaluations 
 
 
The Frontal Fibrosing Alopecia Severity Index (FFASI) is a scoring system designed to 
assess the severity of FFA. It focuses primarily on evaluating the recession of the frontal and 
temporal hairlines, assigning 80 out of 100 points to this criterion. Additional points are allocated 
based on factors such as inflammation, eyebrow loss, face papules, cutaneous lichen planus (LP), 
oral or genital LP lesions, and nail involvement. 
The construct validity of the Frontal Fibrosing Alopecia Severity Score (FFASS) was 
established through its correlation with other severity measures, clinical features, the Lichen 
Planopilaris Activity Index (LPPAI) and the Investigator's Global Assessment. Intra-observer and 
interobserver reliability tests were also carried out. 
The Lichen Planopilaris Activity Index (LPPAI) is a numerical scoring system used to 
quantify the signs and symptoms of FFA and LPP for statistical analysis. Prior to the development 
of FFASI and FFASS, hair specialists commonly relied on the LPPAI to evaluate these conditions. 
The LPPAI assigns weights to subjective and objective measurements, resulting in a score ranging 
from 0 to 10. Symptoms and indicators are assessed on a 4-point scale from absent to severe. The 
anagen pull test, which involves pulling hair shafts to assess for anagen hairs, is used to gauge 


local disease activity and is recorded as a binary value and as the ratio of anagen hairs to total hairs 
pulled. 
 
 
Data analysis 
 
For this research investigation, data collection adheres to a specific format with discrete 
entries to uphold participant anonymity and confidentiality. Patient-specific data remains 
confidential, accessible only to authorized personnel, and is not included in any public records.  
The data analysis process involved using descriptive statistics for qualitative data and the 
median with interquartile range for quantitative data. Statistical tests were applied to evaluate the 
effectiveness and safety of oral tofacinib before and after treatment in patients with recalcitrant 
FFA. A p-value of ≤0.05 was considered statistically significant, indicating a meaningful 
difference between pre- and post-treatment outcomes.