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Alopecia AreataPhase 4MTX-MNX-AANCT07459933

Topical Methotrexate vs Minoxidil for Localized Alopecia Areata

A Phase 4 study testing Methotrexate 1% Topical Gel and Minoxidil 5% Topical Spray in people with Alopecia Areata, run by Jinnah Postgraduate Medical Centre.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Alopecia areata is an autoimmune disorder characterized by well-defined, non-scarring patches of hair loss on the scalp and other hair-bearing areas. Although several treatment options are available, there is no universally accepted standard therapy, and treatment responses vary widely among patients. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Alopecia Areata
What is being tested?
Methotrexate 1% Topical Gel and Minoxidil 5% Topical Spray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
No sites listed yet
Study dates
15 Mar 2026to 15 Sep 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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients aged 18 to 50 years.
  • Patients of either gender.
  • Patients diagnosed with localized alopecia areata, defined as one or more smooth, well-circumscribed patches of non-scarring hair loss on the scalp with less than 25% scalp involvement, assessed using the Severity of Alopecia Tool (SALT) score.
  • Patients not previously treated with topical methotrexate or minoxidil for alopecia areata.
  • Patients willing to provide written informed consent and comply with follow-up visits.

Who cannot join

  • Patients with other types of alopecia, including androgenetic alopecia, telogen effluvium, or scarring alopecia.
  • Patients with systemic diseases that may influence hair growth or treatment response, such as uncontrolled thyroid disease, uncontrolled diabetes mellitus, or autoimmune connective tissue disorders.
  • Pregnant or lactating women.
  • Patients who have used topical or systemic treatment for alopecia areata within the past 3 months.
  • Patients with known hypersensitivity or allergy to methotrexate or minoxidil.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nimra Khan PGR, FCPS contact

+92 347 2454728

drndkhan458@gmail.com

About this study

Official title: Comparative Study Between Topical Methotrexate 1% Gel and Minoxidil 5% Spray in the Treatment of Localized Alopecia Areata: A Randomized Controlled Trial

Alopecia areata is an autoimmune disorder characterized by well-defined, non-scarring patches of hair loss on the scalp and other hair-bearing areas. Although several treatment options are available, there is no universally accepted standard therapy, and treatment responses vary widely among patients.

Minoxidil is commonly used for hair regrowth due to its ability to stimulate hair follicles and prolong the anagen phase of the hair cycle. Methotrexate, an immunosuppressive agent traditionally used in inflammatory and autoimmune diseases, has also been explored as a potential treatment for alopecia areata because of its ability to suppress immune-mediated follicular damage.

This randomized controlled trial aims to compare the efficacy and safety of topical methotrexate 1% gel versus minoxidil 5% spray in patients with localized alopecia areata. Eligible participants will be randomly assigned to receive either topical methotrexate gel or minoxidil spray and will be followed for 24 weeks. Treatment response will be assessed using the Severity of Alopecia Tool (SALT) score. The findings of this study may help identify an effective therapeutic option for patients with localized alopecia areata and contribute to improving clinical management strategies for this condition.

Read the detailed description

Alopecia areata (AA) is a chronic autoimmune disorder characterized by patchy, non-scarring hair loss resulting from immune-mediated damage to hair follicles. The disease affects approximately 2% of the general population during their lifetime and can have significant psychosocial and cosmetic implications for affected individuals. Despite its relatively high prevalence, management of alopecia areata remains challenging due to variable treatment responses and the absence of a universally accepted therapeutic protocol.

Topical minoxidil is widely used in clinical practice for various types of hair loss, including alopecia areata. It promotes hair regrowth by increasing follicular blood flow, prolonging the anagen phase of the hair cycle, and stimulating hair follicle activity. Several studies have demonstrated improvement in hair density and reduction in SALT scores with the use of topical minoxidil.

Methotrexate, a folic acid antagonist with immunosuppressive and anti-inflammatory properties, has traditionally been used for the treatment of autoimmune and inflammatory conditions such as psoriasis and rheumatoid arthritis. Its immunomodulatory effects have also been explored in alopecia areata, where it may reduce the autoimmune response directed against hair follicles. Recent studies have suggested that topical methotrexate formulations may provide clinical benefit with fewer systemic adverse effects compared to oral therapy.

Given the differing mechanisms of action of these two agents-minoxidil acting primarily through follicular stimulation and methotrexate acting through immune modulation-direct comparison of their therapeutic efficacy may provide valuable insights into optimal management strategies for localized alopecia areata.

This randomized controlled trial will be conducted at the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Eligible participants aged 18-50 years with localized alopecia areata involving less than 25% of the scalp will be enrolled. Participants will be randomly assigned to receive either topical methotrexate 1% gel or minoxidil 5% spray applied twice daily for a period of 24 weeks.

The primary outcome measure will be improvement in hair regrowth assessed by change in Severity of Alopecia Tool (SALT) score from baseline to week 24. Secondary outcomes will include categorization of treatment response (no change, mild improvement, moderate improvement, significant improvement, or complete regrowth) and assessment of treatment safety through monitoring of adverse events such as local irritation, contact dermatitis, folliculitis, or systemic symptoms.

The results of this study are expected to provide evidence regarding the comparative effectiveness and safety of topical methotrexate and minoxidil in the treatment of localized alopecia areata. This may help guide clinicians in selecting appropriate therapeutic strategies and contribute to improving outcomes for patients affected by this autoimmune hair loss disorder.

Conditions
Alopecia Areata
Being tested
Methotrexate 1% Topical Gel, Minoxidil 5% Topical Spray
Keywords
Localized Alopecia Areata, Topical Methotrexate, Minoxidil 5%, Hair Regrowth, Autoimmune Hair Loss, SALT Score
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methotrexate 1% Topical GelDrug

    Topical methotrexate 1% gel will be applied to the affected areas of the scalp twice daily for a duration of 24 weeks. Methotrexate acts as an immunomodulatory agent that suppresses autoimmune inflammation directed against hair follicles in alopecia areata.

  • Minoxidil 5% Topical SprayDrug

    Minoxidil 5% spray will be applied to the affected areas of the scalp twice daily for 24 weeks. Minoxidil promotes hair regrowth by enhancing follicular blood flow, prolonging the anagen phase of the hair cycle, and stimulating hair follicle activity.

Study groups in NCT07459933
Study groupRoleWhat they receive
Topical Methotrexate 1% GelExperimentalParticipants in this arm will receive topical methotrexate 1% gel applied to affected scalp areas twice daily for 24 weeks. Treatment response will be assessed using the Severity of Alopecia Tool (SALT) score at baseline and during follow-up visits at weeks 4, 12, and 24.
Receives: Drug: Methotrexate 1% Topical Gel
Topical Minoxidil 5% SprayActive comparatorParticipants in this arm will receive topical minoxidil 5% spray applied to affected scalp areas twice daily for 24 weeks. Treatment response will be assessed using the Severity of Alopecia Tool (SALT) score at baseline and during follow-up visits at weeks 4, 12, and 24.
Receives: Drug: Minoxidil 5% Topical Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Severity of Alopecia Tool (SALT) Score

    The primary outcome will be the change in Severity of Alopecia Tool (SALT) score from baseline to week 24. SALT score represents the percentage of scalp hair loss. Treatment efficacy will be determined by comparing baseline SALT score with SALT score measured during follow-up. Participants achieving ≥51% reduction in SALT score at week 24 will be considered to have significant treatment response.

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Sep 2026 (estimated)

Resources

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 with localized alopecia areata will be randomly assigned to one of two parallel treatment groups. Group A will receive topical methotrexate 1% gel, while Group B will receive minoxidil 5% spray. Both groups will apply the assigned treatment twice daily for 24 weeks. Treatment response will be assessed using the Severity of Alopecia Tool (SALT) score at baseline and during follow-up visits at weeks 4, 12, and 24.
Masking
None (open label)
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459933
Sponsor's protocol ID
JPMC-DERM-AA-2026-01
Acronym
MTX-MNX-AA
Status last verified
Mar 2026
First submitted
4 Mar 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data generated during this study will not be publicly shared in order to protect participant confidentiality and comply with institutional ethical guidelines. The dataset contains sensitive clinical information and the study was not originally designed with provisions for open data sharing. However, de-identified data may be made available from the corresponding author upon reasonable request, subject to approval by the institutional review board and relevant regulatory authorities.

Publications

  • Ahmed G, Khare S, Ganguly S, Chhabra N, Prabha N. Topical methotrexate 1% gel for the treatment of localized alopecia areata. Int J Dermatol. 2020 Aug;59(8):e292-e293. doi: 10.1111/ijd.14898. Epub 2020 Apr 28. No abstract available.

    PubMed 32346854
  • Alshahrani AA, Al-Tuwaijri R, Abuoliat ZA, Alyabsi M, AlJasser MI, Alkhodair R. Prevalence and Clinical Characteristics of Alopecia Areata at a Tertiary Care Center in Saudi Arabia. Dermatol Res Pract. 2020 Mar 13;2020:7194270. doi: 10.1155/2020/7194270. eCollection 2020.

    PubMed 32231700
  • Olayinka JJT, Richmond JM. Immunopathogenesis of alopecia areata. Curr Res Immunol. 2021 Feb 6;2:7-11. doi: 10.1016/j.crimmu.2021.02.001. eCollection 2021.

    PubMed 35492401
  • Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019 Jun;180(6):1377-1389. doi: 10.1111/bjd.17463. Epub 2019 Feb 21.

    PubMed 30501016
  • Ghassemi M, Yazdanian N, Behrangi E, Jafari M, Goodarzi A. Comparison of efficacy, safety and satisfaction of latanoprost versus minoxidil, betamethasone and in combination in patients with alopecia areata: A blinded multiple group randomized controlled trial. Dermatol Ther. 2022 Dec;35(12):e15943. doi: 10.1111/dth.15943. Epub 2022 Oct 25.

    PubMed 36257912
  • Islam N, Leung PS, Huntley AC, Gershwin ME. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015 Feb;14(2):81-9. doi: 10.1016/j.autrev.2014.10.014. Epub 2014 Oct 12.

    PubMed 25315746
  • Mao Y, Xu Z, Song J, Xie Y, Mei X, Shi W. Efficacy of a mixed preparation containing piperine, capsaicin and curcumin in the treatment of alopecia areata. J Cosmet Dermatol. 2022 Oct;21(10):4510-4514. doi: 10.1111/jocd.14931. Epub 2022 Apr 24.

    PubMed 35318791
  • Toma DM, Atallah RB, Eldahshan RM. Comparative study between topical methotrexate 1% gel and minoxidil 5% gel in the treatment of localized alopecia areata. Dermatol Ther. 2022 Sep;35(9):e15696. doi: 10.1111/dth.15696. Epub 2022 Jul 26.

    PubMed 35796224

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methotrexate 1% Topical Gel and Minoxidil 5% Topical Spray in people with Alopecia Areata, run by Jinnah Postgraduate Medical Centre.

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 5 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: opening soon, as of the sponsor's last update on 10 Mar 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 Nimra Khan PGR, FCPS (+92 347 2454728, drndkhan458@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: Baseline to Week 24). 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 NCT07459933, which also lists 8 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 10 Mar 2026.

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