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Topical Methotrexate vs Minoxidil for Localized Alopecia Areata

NCT07459933 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2026-03-10

No results posted yet for this study

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

Interventions

DRUG

Methotrexate 1% Topical Gel

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.

DRUG

Minoxidil 5% Topical Spray

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.

Sponsors & Collaborators

  • Jinnah Postgraduate Medical Centre

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-09-15
Completion
2026-09-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07459933 on ClinicalTrials.gov