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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.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib | Experimental | taking oral Tofacitinib 5 mg twice a day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib 5 MG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA) | 16 weeks after taking oral Tofacitinib |
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Inclusion Criteria:
Thai males or females who were at least 18 years old
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)
Participants who were diagnosed with recalcitrant frontal fibrosing alopecia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chinmanat Lekhavat, MD | Institute of Dermatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hair and Nail center, Institute of Dermatology | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 148 | Background | Autrup H, Thurlow BJ, Warwick GP. The effects of the continuous administration of N,N-dimethyl-4-phenylazoaniline (DAB) on the activities and the inducibilities of some drug-metabolizing enzymes in rat liver. Chem Biol Interact. 1975 Nov;11(5):313-28. doi: 10.1016/0009-2797(75)90001-0. | |
| 27711196 | Background | Alves de Medeiros AK, Speeckaert R, Desmet E, Van Gele M, De Schepper S, Lambert J. JAK3 as an Emerging Target for Topical Treatment of Inflammatory Skin Diseases. PLoS One. 2016 Oct 6;11(10):e0164080. doi: 10.1371/journal.pone.0164080. eCollection 2016. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib | oral tofacitinib 5 mg twice a day for 12 weeks 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Standard Deviation | score on a scale | 16 weeks after taking oral Tofacitinib |
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypercholesterolemia | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chinmanat Lekhavat | Institute of dermatology, Thailand | +66 95-207-2870 | chinmanat@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2023 | Apr 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
|
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| Secondary | Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA) | Posted | Number | participants | 16 weeks after taking oral Tofacitinib |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 5 |
| 11 |
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fatique | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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