Topical Methotrexate vs Minoxidil for Localized Alopecia Areata

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Change in Severity of Alopecia Tool (SALT) Score [Срок оценки: Baseline to Week 24]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35796224

Идентификаторы

NCT: NCT07459933 · JPMC-DERM-AA-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗