Frontal Fibrosing AlopeciaTofacitinibNCT06202560
Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
A study testing Tofacitinib 5 MG in people with Frontal Fibrosing Alopecia and Lichen Planopilaris of Scalp, run by Institute of Dermatology, Thailand at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frontal Fibrosing Alopecia, Lichen Planopilaris of Scalp
- What is being tested?
- Tofacitinib 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteThailand
- Study dates
- 29 Nov 2023to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
- Pregnancy
- 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
- Patients who received strong or moderate to strong CYP3A4 agents
- Patients who had positive on HBsAg and/or HCV
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine the efficacy and safety of tofacitinib therapy in Thai patients with recalcitrant frontal fibrosing alopecia.
The main questions are
- 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?
- 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.
Read the 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.
- The researchers require the patients to undergo various blood tests before treatment.
- 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).
- 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.
- The disease symptoms to be assessed include facial papule, LP pigmentosus, pruritus, trichodynia, perifollicular erythema, and hyperkeratosis.
- Frontal Fibrosing Alopecia Severity Index (FFASI)
- Frontal Fibrosing Alopecia Severity Score (FFASS)
- Lichen Planopillaris Activity Index (LPPAI)
- 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.
- 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.
- 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.
- Laboratory tests will be conducted at weeks 4, 12, and 16 to assess the medication's safety.
- Being tested
- Tofacitinib 5 MG
- Keywords
- Tofacitinib, Frontal Fibrosing Alopecia Severity Index (FFASI), Frontal Fibrosing Alopecia Severity Score (FFASS), Lichen Planopilaris Activity Index (LPPAI), Frontal fibrosing alopecia, Lichen planopilaris
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5 MGDrug
Also called Xeljanz
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.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Experimental | taking oral Tofacitinib 5 mg twice a day for 12 weeks Receives: Drug: Tofacitinib 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks after taking oral Tofacitinib
Secondary outcomes (1)
Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA)
Measured: 16 weeks after taking oral Tofacitinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start29 Nov 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Frontal Fibrosing AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Dermatology, Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chinmanat Lekhavat, MD, Study director, Institute of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202560
- Sponsor's protocol ID
- IRB/IEC 022/2566
- Acronym
- Tofacitinib
- Status last verified
- May 2025
- First submitted
- 26 Nov 2023
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 148Alves 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.
PubMed 27711196Banka N, Mubki T, Bunagan MJ, McElwee K, Shapiro J. Frontal fibrosing alopecia: a retrospective clinical review of 62 patients with treatment outcome and long-term follow-up. Int J Dermatol. 2014 Nov;53(11):1324-30. doi: 10.1111/ijd.12479. Epub 2014 Apr 16.
PubMed 24738979Binnion PF, Das Gupta R. Prophylactic antiarrhythmic drug therapy in acute myocardial infarction. Cardiovasc Clin. 1975;7(2):203-17. No abstract available.
PubMed 145Childs JM, Sperling LC. Histopathology of scarring and nonscarring hair loss. Dermatol Clin. 2013 Jan;31(1):43-56. doi: 10.1016/j.det.2012.08.001. Epub 2012 Sep 26.
PubMed 23159175Chern CJ, Beutler E. Biochemical and electrophoretic studies of erythrocyte pyridoxine kinase in white and black Americans. Am J Hum Genet. 1976 Jan;28(1):9-17.
PubMed 2009Craiglow BG, King BA. Tofacitinib Citrate for the Treatment of Vitiligo: A Pathogenesis-Directed Therapy. JAMA Dermatol. 2015 Oct;151(10):1110-2. doi: 10.1001/jamadermatol.2015.1520.
PubMed 26107994Ehrhart IC, Parker PE, Weidner WJ, Dabney JM, Scott JB, Haddy FJ. Coronary vascular and myocardial responses to carotid body stimulation in the dog. Am J Physiol. 1975 Sep;229(3):754-60. doi: 10.1152/ajplegacy.1975.229.3.754.
PubMed 2017Gupta AK, Daigle D, Abramovits W, Vincent KD. XELJANZ (Tofacitinib) for Chronic Plaque Psoriasis. Skinmed. 2015 May-Jun;13(3):227-9. No abstract available.
PubMed 26380510Harries MJ, Meyer K, Chaudhry I, E Kloepper J, Poblet E, Griffiths CE, Paus R. Lichen planopilaris is characterized by immune privilege collapse of the hair follicle's epithelial stem cell niche. J Pathol. 2013 Oct;231(2):236-47. doi: 10.1002/path.4233.
PubMed 23788005Hashmi AA, Rashid K, Ali R, Dowlah TU, Ali AH, Diwan MA, Malik UA, Irfan M, Zia S, Ahmad A. Clinicopathological Features of Alopecia With an Emphasis on Etiology and Histopathological Characteristics of Scarring Alopecia. Cureus. 2022 Aug 3;14(8):e27661. doi: 10.7759/cureus.27661. eCollection 2022 Aug.
PubMed 36072194Ho A, Shapiro J. Medical therapy for frontal fibrosing alopecia: A review and clinical approach. J Am Acad Dermatol. 2019 Aug;81(2):568-580. doi: 10.1016/j.jaad.2019.03.079. Epub 2019 Apr 3.
PubMed 30953702Ibrahim O, Bayart CB, Hogan S, Piliang M, Bergfeld WF. Treatment of Alopecia Areata With Tofacitinib. JAMA Dermatol. 2017 Jun 1;153(6):600-602. doi: 10.1001/jamadermatol.2017.0001.
PubMed 28355451Kerkemeyer KLS, Eisman S, Bhoyrul B, Pinczewski J, Sinclair RD. Frontal fibrosing alopecia. Clin Dermatol. 2021 Mar-Apr;39(2):183-193. doi: 10.1016/j.clindermatol.2020.10.007. Epub 2020 Oct 17.
PubMed 34272007Kossard S. Postmenopausal frontal fibrosing alopecia. Scarring alopecia in a pattern distribution. Arch Dermatol. 1994 Jun;130(6):770-4.
PubMed 8002649
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
- ClinicalTrials.gov ID
- NCT06202560
- Acronym / sponsor ID
- Tofacitinib / IRB/IEC 022/2566
- Keywords
- Tofacitinib, Frontal Fibrosing Alopecia Severity Index (FFASI), Frontal Fibrosing Alopecia Severity Score (FFASS), Lichen Planopilaris Activity Index (LPPAI), Frontal fibrosing alopecia, Lichen planopilaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Institute of Dermatology, ThailandOther government
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the efficacy and safety of tofacitinib therapy in Thai patients with recalcitrant frontal fibrosing alopecia.
The main questions are
- 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?
- 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.
- The researchers require the patients to undergo various blood tests before treatment.
- 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).
- 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.
- The disease symptoms to be assessed include facial papule, LP pigmentosus, pruritus, trichodynia, perifollicular erythema, and hyperkeratosis.
- Frontal Fibrosing Alopecia Severity Index (FFASI)
- Frontal Fibrosing Alopecia Severity Score (FFASS)
- Lichen Planopillaris Activity Index (LPPAI)
- 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.
- 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.
- 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.
- Laboratory tests will be conducted at weeks 4, 12, and 16 to assess the medication's safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | Experimental | Drug: Tofacitinib 5 MGtaking oral Tofacitinib 5 mg twice a day for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Pregnancy
- 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
- Patients who received strong or moderate to strong CYP3A4 agents
- Patients who had positive on HBsAg and/or HCV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tofacitinib 5 MGAlso: XeljanzParticipants 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. | Drug | Tofacitinib |
Primary outcome
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA)
Time frame: 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.
1 secondary outcome
Clinical & Investigation Safety of Oral Tofacitinib in Recalcitrant (FFA)
Time frame: 16 weeks after taking oral Tofacitinib
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 148Autrup 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.
- Background: PubMed 27711196Alves 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.
- Background: PubMed 24738979Banka N, Mubki T, Bunagan MJ, McElwee K, Shapiro J. Frontal fibrosing alopecia: a retrospective clinical review of 62 patients with treatment outcome and long-term follow-up. Int J Dermatol. 2014 Nov;53(11):1324-30. doi: 10.1111/ijd.12479. Epub 2014 Apr 16.
- Background: PubMed 145Binnion PF, Das Gupta R. Prophylactic antiarrhythmic drug therapy in acute myocardial infarction. Cardiovasc Clin. 1975;7(2):203-17. No abstract available.
- Background: PubMed 23159175Childs JM, Sperling LC. Histopathology of scarring and nonscarring hair loss. Dermatol Clin. 2013 Jan;31(1):43-56. doi: 10.1016/j.det.2012.08.001. Epub 2012 Sep 26.
- Background: PubMed 2009Chern CJ, Beutler E. Biochemical and electrophoretic studies of erythrocyte pyridoxine kinase in white and black Americans. Am J Hum Genet. 1976 Jan;28(1):9-17.
- Background: PubMed 26107994Craiglow BG, King BA. Tofacitinib Citrate for the Treatment of Vitiligo: A Pathogenesis-Directed Therapy. JAMA Dermatol. 2015 Oct;151(10):1110-2. doi: 10.1001/jamadermatol.2015.1520.
- Background: PubMed 2017Ehrhart IC, Parker PE, Weidner WJ, Dabney JM, Scott JB, Haddy FJ. Coronary vascular and myocardial responses to carotid body stimulation in the dog. Am J Physiol. 1975 Sep;229(3):754-60. doi: 10.1152/ajplegacy.1975.229.3.754.
- Background: PubMed 26380510Gupta AK, Daigle D, Abramovits W, Vincent KD. XELJANZ (Tofacitinib) for Chronic Plaque Psoriasis. Skinmed. 2015 May-Jun;13(3):227-9. No abstract available.
- Background: PubMed 23788005Harries MJ, Meyer K, Chaudhry I, E Kloepper J, Poblet E, Griffiths CE, Paus R. Lichen planopilaris is characterized by immune privilege collapse of the hair follicle's epithelial stem cell niche. J Pathol. 2013 Oct;231(2):236-47. doi: 10.1002/path.4233.
- Background: PubMed 36072194Hashmi AA, Rashid K, Ali R, Dowlah TU, Ali AH, Diwan MA, Malik UA, Irfan M, Zia S, Ahmad A. Clinicopathological Features of Alopecia With an Emphasis on Etiology and Histopathological Characteristics of Scarring Alopecia. Cureus. 2022 Aug 3;14(8):e27661. doi: 10.7759/cureus.27661. eCollection 2022 Aug.
- Background: PubMed 30953702Ho A, Shapiro J. Medical therapy for frontal fibrosing alopecia: A review and clinical approach. J Am Acad Dermatol. 2019 Aug;81(2):568-580. doi: 10.1016/j.jaad.2019.03.079. Epub 2019 Apr 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chinmanat Lekhavat, MD study director
Institute of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tofacitinib 5 MG in people with Frontal Fibrosing Alopecia and Lichen Planopilaris of Scalp, run by Institute of Dermatology, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Oral Tofacitinib in Recalcitrant Frontal Fibrosing Alopecia(FFA) (time frame: 16 weeks after taking oral Tofacitinib). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06202560, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.