An interventional study of Tofacitinib 5 MG in Frontal Fibrosing Alopecia and Lichen Planopilaris of Scalp, sponsored by Institute of Dermatology, Thailand. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Institute of Dermatology, Thailand · Not applicable, Interventional, and Treatment
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.
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's enrollment of 11 is below the median of 30 across 55 interventional studies indexed under Lichen Planus.
Browse Lichen Planus studies →Institute of Dermatology, Thailand is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants who were diagnosed with recalcitrant frontal fibrosing alopecia
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
taking oral Tofacitinib 5 mg twice a day for 12 weeks
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.
Also known as: Xeljanz
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
Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA)
Time frame: 16 weeks after taking oral Tofacitinib
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.
| Milestone | Tofacitinib |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
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.
| score on a scale | Tofacitinib |
|---|---|
| FFASI at baseline (week 0) | 47.5 ± 13.25 |
| FFASI at week 16 | 44 ± 13.5 |
| FFASS at baseline (week 0) | 16.3 ± 4.07 |
| FFASS at week 16 | 15.9 ± 4.62 |
| LPPAI at baseline (week 0) | 1.83 ± 1.01 |
| LPPAI at week 16 | 1.33 ± 0.49 |
| participants | Tofacitinib |
|---|---|
| mild acne vulgaris | 4 |
| hypercholesterolemia | 5 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tofacitinib | 0/11 (0%) | 0/11 (0%) | 5/11 (45.5%) |
| Event | Tofacitinib |
|---|---|
| hypercholesterolemiaInvestigations | 5/11 |
| AcneSkin and subcutaneous tissue disorders | 4/11 |
| HeadacheMusculoskeletal and connective tissue disorders | 1/11 |
| FatiqueMusculoskeletal and connective tissue disorders | 1/11 |
| Age, Categorical(Participants) | Tofacitinib |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Tofacitinib |
|---|---|
| Female | 11 |
| Male | 0 |
| Race/Ethnicity, Customized(participants) | Tofacitinib |
|---|---|
| asian | 11 |
| Region of Enrollment(participants) | Tofacitinib |
|---|---|
| Thailand | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tofacitinib
Institute of Dermatology, Thailand