Alopecia AreataPhase 4TOFA-MTX-AANCT07406204
Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)
A Phase 4 study testing Tofacitinib and Methotrexate in people with Alopecia Areata and Alopecia Totalis (AT), run by Hayat Abad Medical Complex, Peshawar.
Trial summary
This study will compare two oral medicines-tofacitinib and methotrexate-for treating severe alopecia areata, including alopecia totalis (loss of all scalp hair) and alopecia universalis (loss of scalp and body hair). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis (AT), Alopecia Universalis
- What is being tested?
- Tofacitinib and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Clinical diagnosis of severe alopecia areata, alopecia totalis, or alopecia universalis (as per protocol/operational definition), confirmed by a consultant dermatologist.
- Either sex.
- Able and willing to provide written informed consent.
Who cannot join
- Currently receiving or recently used any systemic treatment intended for hair regrowth for alopecia areata (e.g., systemic corticosteroids, immunosuppressants, JAK inhibitors).
- Pregnant women.
- History or clinical evidence of renal, hepatic, or pulmonary disease.
- Any condition that, in the investigator's judgment, makes participation unsafe or interferes with adherence to the study protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Clinical Efficacy of Tofacitinib Versus Methotrexate in Severe Alopecia Areata, Alopecia Totalis, and Alopecia Universalis: A Randomized Controlled Trial
This study will compare two oral medicines-tofacitinib and methotrexate-for treating severe alopecia areata, including alopecia totalis (loss of all scalp hair) and alopecia universalis (loss of scalp and body hair). Alopecia areata is an autoimmune condition that can cause significant hair loss and emotional distress.
Adults aged 18 to 60 years with severe disease will be enrolled at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar, after ethical approval and written informed consent. Participants will be randomly assigned to receive either tofacitinib 10 mg twice daily or methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks.
The main outcome will be improvement in hair loss measured by the Severity of Alopecia Tool (SALT) score. Treatment will be considered effective if there is more than 50% improvement in SALT score from baseline at the end of 12 weeks. Safety will be monitored during follow-up visits. The findings may help guide treatment decisions for severe alopecia areata in our local population.
Read the detailed description
This is a single-center, parallel-group, randomized controlled trial to compare the clinical efficacy of oral tofacitinib versus methotrexate in adults with severe alopecia areata, including alopecia totalis and alopecia universalis, conducted at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar.
After approvals from the Institutional Ethical Committee and CPSP-REU and after obtaining written informed consent, eligible participants aged 18-60 years with severe alopecia areata/totalis/universalis diagnosed by a consultant dermatologist will be enrolled using consecutive non-probability sampling. Patients already receiving systemic therapy for hair regrowth, pregnant women, and patients with renal, hepatic, or pulmonary disease (based on history and clinical assessment) will be excluded.
Baseline demographic and clinical data will be recorded, and baseline disease severity will be assessed using the Severity of Alopecia Tool (SALT) score. Participants will be randomized using blocked randomization into two treatment arms:
Arm A: Oral tofacitinib 10 mg twice daily for 12 weeks.
Arm B: Oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks, with scheduled follow-up and laboratory monitoring for potential adverse effects as per institutional protocol.
Participants will be reviewed every 4 weeks during treatment. At the end of 12 weeks, the SALT score will be reassessed. The primary endpoint is clinical efficacy defined a priori as >50% improvement in SALT score from baseline at week 12. Safety and tolerability will be assessed through clinical review and routine monitoring during follow-up visits.
Data will be analyzed using SPSS (version 23.0). Quantitative variables (e.g., age, duration of disease, baseline and post-treatment SALT scores) will be summarized as mean ± standard deviation, and categorical variables (e.g., gender, residence, efficacy) will be presented as frequency and percentage. Efficacy between groups will be compared using the chi-square test, and stratification will be performed for age group, gender, residence, and disease duration; post-stratification chi-square testing will be applied. A p-value <0.05 will be considered statistically significant.
- Conditions
- Alopecia Areata, Alopecia Totalis (AT), Alopecia Universalis
- Being tested
- Tofacitinib, Methotrexate
- Keywords
- Tofacitinib, Methotrexate, Janus Kinase Inhibitor, Severe Alopecia Areata, Autoimmune Hair Loss
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Oral tofacitinib 10 mg twice daily for 12 weeks.
MethotrexateDrug
Oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks, with routine monitoring for adverse effects as per institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib 10 mg Twice Daily | Experimental | Participants will receive oral tofacitinib 10 mg twice daily for 12 weeks. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as >50% improvement in SALT score from baseline. Receives: Drug: Tofacitinib |
| Methotrexate 0.2-0.4 mg/kg Weekly | Active comparator | Participants will receive oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks with routine follow-up and laboratory monitoring for adverse effects as per institutional protocol. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as >50% improvement in SALT score from baseline. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of Alopecia Tool (SALT) Score
SALT score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. The primary outcome is the change in SALT score from baseline to week 12, compared between the tofacitinib and methotrexate groups.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to two parallel treatment arms (tofacitinib vs methotrexate) and followed for 12 weeks. Efficacy will be assessed by change in SALT score from baseline to week 12.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hira Rehman, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406204
- Sponsor's protocol ID
- HMC-DERM-TOFA-MTX-AA
- Acronym
- TOFA-MTX-AA
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is an investigator-initiated, single-center study and data sharing is not covered in the participant consent/IRB approvals. De-identified aggregate results will be reported in publications and presentations. De-identified data may be considered for sharing in the future upon reasonable request after publication, subject to additional ethical approvals and a data use agreement.
Publications
Abe DT, Tashima LM, Basilio FMA, Mulinari-Brenner F. Clinical Experience with Oral Tofacitinib in a Patient with Alopecia Areata Universalis and Rheumatoid Arthritis. Int J Trichology. 2020 Jul-Aug;12(4):188-190. doi: 10.4103/ijt.ijt_107_20. Epub 2020 Sep 19.
PubMed 33376289Asma JK, Huma AS, Urooj M. A study on the role of tofacitinib among patients treated with alopecia areata. Pak J Med Health Sc. 2022;16(12):801-3.
Iorizzo M, Tosti A. Emerging drugs for alopecia areata: JAK inhibitors. Expert Opin Emerg Drugs. 2018 Mar;23(1):77-81. doi: 10.1080/14728214.2018.1444750. Epub 2018 Feb 26.
PubMed 29466675Cervantes J, Jimenez JJ, DelCanto GM, Tosti A. Treatment of Alopecia Areata with Simvastatin/Ezetimibe. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S25-S31. doi: 10.1016/j.jisp.2017.10.013.
PubMed 29273101Strazzulla LC, Avila L, Lo Sicco K, Shapiro J. An Overview of the Biology of Platelet-Rich Plasma and Microneedling as Potential Treatments for Alopecia Areata. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S21-S24. doi: 10.1016/j.jisp.2017.10.002.
PubMed 29273100Lee S, Kim BJ, Lee YB, Lee WS. Hair Regrowth Outcomes of Contact Immunotherapy for Patients With Alopecia Areata: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018 Oct 1;154(10):1145-1151. doi: 10.1001/jamadermatol.2018.2312.
PubMed 30073292Ro BI. Alopecia areata in Korea (1982-1994). J Dermatol. 1995 Nov;22(11):858-64. doi: 10.1111/j.1346-8138.1995.tb03936.x.
PubMed 8557859Melo DF, Dutra TBS, Baggieri VMAC, Tortelly VD. Intralesional betamethasone as a therapeutic option for alopecia areata. An Bras Dermatol. 2018 Mar;93(2):311-312. doi: 10.1590/abd1806-4841.20187423. No abstract available.
PubMed 29723356Chu TW, AlJasser M, Alharbi A, Abahussein O, McElwee K, Shapiro J. Benefit of different concentrations of intralesional triamcinolone acetonide in alopecia areata: An intrasubject pilot study. J Am Acad Dermatol. 2015 Aug;73(2):338-40. doi: 10.1016/j.jaad.2015.04.049. No abstract available.
PubMed 26183987Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladden M. British Association of Dermatologists' guidelines for the management of alopecia areata 2012. Br J Dermatol. 2012 May;166(5):916-26. doi: 10.1111/j.1365-2133.2012.10955.x. No abstract available.
PubMed 22524397Rajabi F, Drake LA, Senna MM, Rezaei N. Alopecia areata: a review of disease pathogenesis. Br J Dermatol. 2018 Nov;179(5):1033-1048. doi: 10.1111/bjd.16808. Epub 2018 Sep 9.
PubMed 29791718Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014 Apr;134(4):1141-1142. doi: 10.1038/jid.2013.464. Epub 2013 Nov 11. No abstract available.
PubMed 24202232Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ 3rd. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995 Jul;70(7):628-33. doi: 10.4065/70.7.628.
PubMed 7791384Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.
PubMed 28300084Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med. 2012 Apr 19;366(16):1515-25. doi: 10.1056/NEJMra1103442. No abstract available.
PubMed 22512484
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Efficacy of Tofacitinib Versus Methotrexate in Severe Alopecia Areata, Alopecia Totalis, and Alopecia Universalis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07406204
- Acronym / sponsor ID
- TOFA-MTX-AA / HMC-DERM-TOFA-MTX-AA
- Conditions
- Alopecia Areata, Alopecia Totalis (AT), Alopecia Universalis
- Keywords
- Tofacitinib, Methotrexate, Janus Kinase Inhibitor, Severe Alopecia Areata, Autoimmune Hair Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two oral medicines-tofacitinib and methotrexate-for treating severe alopecia areata, including alopecia totalis (loss of all scalp hair) and alopecia universalis (loss of scalp and body hair). Alopecia areata is an autoimmune condition that can cause significant hair loss and emotional distress.
Adults aged 18 to 60 years with severe disease will be enrolled at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar, after ethical approval and written informed consent. Participants will be randomly assigned to receive either tofacitinib 10 mg twice daily or methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks.
The main outcome will be improvement in hair loss measured by the Severity of Alopecia Tool (SALT) score. Treatment will be considered effective if there is more than 50% improvement in SALT score from baseline at the end of 12 weeks. Safety will be monitored during follow-up visits. The findings may help guide treatment decisions for severe alopecia areata in our local population.
Detailed description
This is a single-center, parallel-group, randomized controlled trial to compare the clinical efficacy of oral tofacitinib versus methotrexate in adults with severe alopecia areata, including alopecia totalis and alopecia universalis, conducted at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar.
After approvals from the Institutional Ethical Committee and CPSP-REU and after obtaining written informed consent, eligible participants aged 18-60 years with severe alopecia areata/totalis/universalis diagnosed by a consultant dermatologist will be enrolled using consecutive non-probability sampling. Patients already receiving systemic therapy for hair regrowth, pregnant women, and patients with renal, hepatic, or pulmonary disease (based on history and clinical assessment) will be excluded.
Baseline demographic and clinical data will be recorded, and baseline disease severity will be assessed using the Severity of Alopecia Tool (SALT) score. Participants will be randomized using blocked randomization into two treatment arms:
Arm A: Oral tofacitinib 10 mg twice daily for 12 weeks.
Arm B: Oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks, with scheduled follow-up and laboratory monitoring for potential adverse effects as per institutional protocol.
Participants will be reviewed every 4 weeks during treatment. At the end of 12 weeks, the SALT score will be reassessed. The primary endpoint is clinical efficacy defined a priori as >50% improvement in SALT score from baseline at week 12. Safety and tolerability will be assessed through clinical review and routine monitoring during follow-up visits.
Data will be analyzed using SPSS (version 23.0). Quantitative variables (e.g., age, duration of disease, baseline and post-treatment SALT scores) will be summarized as mean ± standard deviation, and categorical variables (e.g., gender, residence, efficacy) will be presented as frequency and percentage. Efficacy between groups will be compared using the chi-square test, and stratification will be performed for age group, gender, residence, and disease duration; post-stratification chi-square testing will be applied. A p-value <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to two parallel treatment arms (tofacitinib vs methotrexate) and followed for 12 weeks. Efficacy will be assessed by change in SALT score from baseline to week 12.
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib 10 mg Twice Daily | Experimental | Drug: TofacitinibParticipants will receive oral tofacitinib 10 mg twice daily for 12 weeks. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as >50% improvement in SALT score from baseline. |
| Methotrexate 0.2-0.4 mg/kg Weekly | Active comparator | Drug: MethotrexateParticipants will receive oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks with routine follow-up and laboratory monitoring for adverse effects as per institutional protocol. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as >50% improvement in SALT score from baseline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-60 years.
- Clinical diagnosis of severe alopecia areata, alopecia totalis, or alopecia universalis (as per protocol/operational definition), confirmed by a consultant dermatologist.
- Either sex.
- Able and willing to provide written informed consent.
Key exclusion criteria (4 listed)
- Currently receiving or recently used any systemic treatment intended for hair regrowth for alopecia areata (e.g., systemic corticosteroids, immunosuppressants, JAK inhibitors).
- Pregnant women.
- History or clinical evidence of renal, hepatic, or pulmonary disease.
- Any condition that, in the investigator's judgment, makes participation unsafe or interferes with adherence to the study protocol.
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 |
|---|---|---|
| TofacitinibOral tofacitinib 10 mg twice daily for 12 weeks. | Drug | Tofacitinib 10 mg Twice Daily |
| MethotrexateOral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks, with routine monitoring for adverse effects as per institutional protocol. | Drug | Methotrexate 0.2-0.4 mg/kg Weekly |
Primary outcome
Change in Severity of Alopecia Tool (SALT) Score
Time frame: Week 12
SALT score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. The primary outcome is the change in SALT score from baseline to week 12, compared between the tofacitinib and methotrexate groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Results publication: PubMed 33376289Abe DT, Tashima LM, Basilio FMA, Mulinari-Brenner F. Clinical Experience with Oral Tofacitinib in a Patient with Alopecia Areata Universalis and Rheumatoid Arthritis. Int J Trichology. 2020 Jul-Aug;12(4):188-190. doi: 10.4103/ijt.ijt_107_20. Epub 2020 Sep 19.
- Results publicationAsma JK, Huma AS, Urooj M. A study on the role of tofacitinib among patients treated with alopecia areata. Pak J Med Health Sc. 2022;16(12):801-3.
- Results publication: PubMed 29466675Iorizzo M, Tosti A. Emerging drugs for alopecia areata: JAK inhibitors. Expert Opin Emerg Drugs. 2018 Mar;23(1):77-81. doi: 10.1080/14728214.2018.1444750. Epub 2018 Feb 26.
- Results publication: PubMed 29273101Cervantes J, Jimenez JJ, DelCanto GM, Tosti A. Treatment of Alopecia Areata with Simvastatin/Ezetimibe. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S25-S31. doi: 10.1016/j.jisp.2017.10.013.
- Results publication: PubMed 29273100Strazzulla LC, Avila L, Lo Sicco K, Shapiro J. An Overview of the Biology of Platelet-Rich Plasma and Microneedling as Potential Treatments for Alopecia Areata. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S21-S24. doi: 10.1016/j.jisp.2017.10.002.
- Results publication: PubMed 30073292Lee S, Kim BJ, Lee YB, Lee WS. Hair Regrowth Outcomes of Contact Immunotherapy for Patients With Alopecia Areata: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018 Oct 1;154(10):1145-1151. doi: 10.1001/jamadermatol.2018.2312.
- Results publication: PubMed 8557859Ro BI. Alopecia areata in Korea (1982-1994). J Dermatol. 1995 Nov;22(11):858-64. doi: 10.1111/j.1346-8138.1995.tb03936.x.
- Results publication: PubMed 29723356Melo DF, Dutra TBS, Baggieri VMAC, Tortelly VD. Intralesional betamethasone as a therapeutic option for alopecia areata. An Bras Dermatol. 2018 Mar;93(2):311-312. doi: 10.1590/abd1806-4841.20187423. No abstract available.
- Results publication: PubMed 26183987Chu TW, AlJasser M, Alharbi A, Abahussein O, McElwee K, Shapiro J. Benefit of different concentrations of intralesional triamcinolone acetonide in alopecia areata: An intrasubject pilot study. J Am Acad Dermatol. 2015 Aug;73(2):338-40. doi: 10.1016/j.jaad.2015.04.049. No abstract available.
- Results publication: PubMed 22524397Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladden M. British Association of Dermatologists' guidelines for the management of alopecia areata 2012. Br J Dermatol. 2012 May;166(5):916-26. doi: 10.1111/j.1365-2133.2012.10955.x. No abstract available.
- Results publication: PubMed 29791718Rajabi F, Drake LA, Senna MM, Rezaei N. Alopecia areata: a review of disease pathogenesis. Br J Dermatol. 2018 Nov;179(5):1033-1048. doi: 10.1111/bjd.16808. Epub 2018 Sep 9.
- Results publication: PubMed 24202232Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014 Apr;134(4):1141-1142. doi: 10.1038/jid.2013.464. Epub 2013 Nov 11. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is an investigator-initiated, single-center study and data sharing is not covered in the participant consent/IRB approvals. De-identified aggregate results will be reported in publications and presentations. De-identified data may be considered for sharing in the future upon reasonable request after publication, subject to additional ethical approvals and a data use agreement.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tofacitinib and Methotrexate in people with Alopecia Areata and Alopecia Totalis (AT), run by Hayat Abad Medical Complex, Peshawar.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hira Rehman, FCPS (03359849292, khira420.hr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Severity of Alopecia Tool (SALT) Score (time frame: Week 12). 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 NCT07406204, which also lists 15 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 12 Feb 2026.