Topical Methotrexate vs Minoxidil for Localized Alopecia Areata
ConditionAlopecia Areata
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorJinnah Postgraduate Medical Centre
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Methotrexate 1% Topical Gel
DrugTopical 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 Spray
DrugMinoxidil 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.
Treatment groups
268 Participants
are divided into 2 treatment groupsGroup A: Topical Methotrexate 1% GelExperimental treatment 1 intervention
Group B: Topical Minoxidil 5% SprayActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to Week 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: