Topical Methotrexate vs Minoxidil for Localized Alopecia Areata

NCT07459933 | Not Yet Recruiting Phase 4

• 1 other identifier: JPMC-DERM-AA-2026-01
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Alopecia Areata

Keywords

Localized Alopecia Areata; Topical Methotrexate; Minoxidil 5%; Hair Regrowth; Autoimmune Hair Loss; SALT Score

Outcome Measures

Primary Outcomes (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.

  Baseline to Week 24

Study Arms (2)

Topical Methotrexate 1% Gel

EXPERIMENTAL

Participants 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.

Drug: Methotrexate 1% Topical Gel

Topical Minoxidil 5% Spray

ACTIVE COMPARATOR

Participants 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.

Drug: Minoxidil 5% Topical Spray

Interventions

Methotrexate 1% Topical Gel DRUG

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.

Topical Methotrexate 1% Gel

Minoxidil 5% Topical Spray DRUG

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.

Topical Minoxidil 5% Spray

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Related Publications (8)

• 8. 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;59(8):e292-e293.

  RESULT

• 7. Alshahrani AA, Al-Tuwaijri R, Abuoliat ZA, Alyabsi M, AlJasser MI, Alkhodair R, et al. Prevalence and clinical characteristics of alopecia areata at a tertiary care center in Saudi Arabia. Dermatol Res Pract. 2020;2020:7194270

  RESULT

• 6. Olayinka JT, Richmond JM. Immunopathogenesis of alopecia areata. Curr Res Immunol. 2021;2:7-11.

  RESULT

• 5. Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019;180(6):1377-19.

  RESULT

• 4. 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;35(12):e15943.

  RESULT

• 3. Islam N, Leung PS, Huntley AC, Gershwin ME. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015;14(2):81-89

  RESULT

• 2. Mao Y, Xu Z, Song J, Xie Y, Mei X, Shi W, et al. Efficacy of a mixed preparation containing piperine, capsaicin and curcumin in the treatment of alopecia areata. J Cosmet Dermatol. 2022;21(10):4510-14

  RESULT

• 1. 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;35(9):e15696.

  RESULT

MeSH Terms

Conditions

Alopecia Areata

Interventions

Methotrexate; Gels; Minoxidil

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Piperidines; Heterocyclic Compounds, 1-Ring; Pyrimidines

Central Study Contacts

Nimra Khan PGR, FCPS

CONTACT

+92 347 2454728; drndkhan458@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators will be aware of the assigned treatment because the study medications differ in formulation (topical methotrexate gel versus minoxidil spray). Therefore, the study will be conducted as an open-label randomized controlled trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGR

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share