Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study

Frontal Fibrosing Alopecia Clinical Trial

— Tofacitinib  

Official title:

Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06202560
• Other study ID #: IRB/IEC 022/2566
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: January 2024
• Source: Institute of Dermatology, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to study 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.

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), as well as 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 receiving treatment. 3. The researchers collect data on the patients' skin conditions using 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-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. 1. The symptoms of the disease to be assessed include facial papule, LP pigmentosus, pruritus, trichodynia, perifollicular erythema, and perifollicular 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, and 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 to assess the safety of the medication at weeks 4, 12, and 16.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 11
• Est. completion date: May 15, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Frontal Fibrosing Alopecia
• Lichen Planopilaris
• Lichen Planus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Thailand	Hair and Nail center, Institute of Dermatology	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Dermatology, Thailand

Country where clinical trial is conducted

Thailand, 

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	16 weeks after taking oral Tofacitinib
Secondary	Clinical & Investigation Safety of oral tofacitinib in recalcitrant (FFA)	The safety of clinical and laboratory investigation and oral Tofacitinib treatment is evident, as patients do not experience any complaints of abnormal symptoms after taking the drugs. These symptoms may include respiratory tract infections, skin abnormalities, gastrointestinal abnormalities, urinary tract infections, or other adverse events at weeks 4, 12, and 16.	16 weeks after taking oral Tofacitinib