Alopecia areata (AA) is a prevalent, non-scarring, recurrent, chronic condition characterized by an unpredictable progression that can impact any area with hair. It encompasses various forms, including diffuse type, patchy type, total type affecting the entire scalp, and universalis affecting the entire body. AA is an autoimmune inflammatory disorder characterized by T lymphocyte-mediated targeting of hair follicles, however its pathophysiology remains incompletely elucidated [1]. AA can induce significant psychological suffering and diminish patients' confidence [2]. The paramount feature of management is to advise the patient regarding the unpredictable nature and progression of the ailment, as well as to address the obstacles associated with therapeutic modalities that exhibit fluctuating efficacy and undesirable effects [3,4]. AA impacts approximately 2% of the worldwide population, affecting individuals of all ages, though it is more common in youngsters. AA is characterized by its chronic nature, marked by repeated relapses, and the majority of therapy exhibit diminished efficacy upon discontinuation [6]. Typically, numerous therapy modalities have demonstrated efficacy in promoting hair growth in alopecia areata. The research about their long-term efficacy and effect on quality of life remains insufficient. Numerous specialists see intralesional corticosteroid therapy as the optimal treatment for localized scalp alopecia areata. Adverse consequences including injection discomfort, skin shrinkage, and telangiectasia. The relapse rate is 29% [7]. Topical Betamethasone dipropionate/valerate generally results in 75% hair regrowth, whereas telangiectasia, folliculitis, and atrophy may occur seldom. The relapse rate ranges from 37% to 63% [8]. Patients treated with minoxidil have demonstrated cosmetically satisfactory hair regrowth in 63.6% of instances. Topical minoxidil may cause undesirable effects such as contact dermatitis, face hypertrichosis, dryness, scaling, itching, and/or erythema [9]. The documented relapse rate ranges from 37% to 63%. Tretinoin promotes hair regrowth in roughly 58% of the participants examined, with side effects including skin irritation, dryness, erythema, desquamation, and burning sensations, as well as photosensitivity in some instances. It is not universally effective and is probably less efficacious than conventional treatments such as topical steroids [10]. Methotrexate (4-amino-N-methylpteroylglutamic acid) is a folic acid antagonist and an aminopterin derivative, approved as an antineoplastic agent in 1953 and for psoriasis treatment in 1971. As an immunosuppressant, Methotrexate is utilized in the management of various dermatological conditions, including psoriasis, bullous dermatoses, collagen storage disorders, vasculitides, neutrophilic dermatoses, and atopic dermatitis. Recently, oral doses of 15–25 mg weekly have been employed in the treatment of AA, yielding good outcomes [11]. Full hair regrowth was attained in 57% of instances. Adverse effects of oral methotrexate encompass chronic nausea, temporary increase of liver enzymes, and leucopenia [12]. To mitigate undesirable effects associated with oral methotrexate, topical methotrexate gel is currently being used for alopecia areata (AA) [13]. There is less data on definitive proof about the efficacy of topical methotrexate in alopecia areata.

Study Design:

This is a prospective cross-sectional study conducted to evaluate the efficacy of 1% methotrexate gel in patients with Alopecia Areata.

Study Setting and Population:

The study was conducted at the outpatient facility of the Department of Dermatology, Venereology, and Leprosy, M.Y. Hospital, Indore. All patients presenting with Alopecia Areata were considered for inclusion.

Study Period:

The study was carried out over 12 months after obtaining approval from the Institutional Ethical Committee.

Sample Size:

A total of 30 patients diagnosed with Alopecia Areata were included in the study.

Inclusion Criteria:

• Patients clinically diagnosed with Alopecia Areata.
• Age above 18 years.
• Willingness to provide informed consent and comply with follow-up visits every 4 weeks.

Exclusion Criteria:

• Subjects not consenting to participate in the study.
• Patients requiring systemic treatment to control the disease.
• Pregnant females.

Apparatus and Materials:

• Methotrexate gel (1%).

Procedure:

• All patients were administered 1% methotrexate gel twice daily on affected areas.
• Patients were advised not to use any other topical or oral medications during the study period.
• Severity of Alopecia Areata was assessed using the Severity of Alopecia Tool (SALT) at baseline (0), 2, 4, and 6 weeks to evaluate the extent and improvement of hair loss.
• Written informed consent was obtained from all participants after providing a detailed explanation of the study's purpose and voluntary nature.

Ethical Consideration:

• Ethical approval was obtained from the Institutional Review Board and Ethics Committee of MGM Medical College, Indore.
• Confidentiality of patient information was maintained throughout the study.

Data Compilation and Statistical Analysis:

• Data were compiled using MS Excel and analyzed using SPSS software version 20.
• Descriptive statistics were used to summarize demographic and clinical characteristics.
• Changes in the SALT scores were analyzed using paired t-tests, with a p-value < 0.05 considered statistically significant.

Table 1: Baseline Demographics for Alopecia Areata (n=30)

In a study of 30 patients with Alopecia Areata, the majority were male (66.7%), while females constituted 33.3% of the group. The age distribution showed that 30.0% were between 11-20 years, 33.3% were 21-30 years, another 30.0% were 31-40 years, and 6.7% were over 40, with a mean age of 27.53±9.78 years. All patients (100.0%) had the disease for 6 months or less, with a mean duration of 4.99±8.51 months. The most commonly affected site was the scalp (93.3%), followed by the eyebrows (6.7%).

Table 2: Distribution According to Occupation for Alopecia Areata (n=30)

In a study of 30 patients with Alopecia Areata, the most common occupation was students, comprising 33.3% of the group, followed by housewives at 20.0%. Labourers and those with private jobs each made up 10.0%, while farmers and teachers each accounted for 6.7%. Smaller proportions were observed among drivers, engineers, shopkeepers, and unemployed individuals, each representing 3.3% of the study population. This distribution highlights the varied occupational backgrounds of individuals affected by Alopecia Areata.

Table. 3 SALT Score change from baseline at 2, 4 and 6 weeks in Alopecia Acreta group

All comparisons done from baseline

Paired ‘t’ test applied. P value <0.05 was considered as statistically significant

The above table shows the SALT Score change from baseline at 2, 4 and 6 weeks in Alopecia Acreta group.

The mean SALT Score at baseline in psoriasis group was 11.68 ± 5.23; at 2 weeks, it was 11.68 ± 5.23; at 4 weeks, it was 10.88 ± 5.59 and at 6 weeks, it was 10.45 ±5.39.

There was a persistent significant reduction in the mean SALT Score at 4 weeks and 6 weeks compared to baseline (P<0.05), while no change in mean SALT score was seen at 2 weeks compared to baseline.

Table 4 Mean percentage reduction

The mean SALT score for patients at baseline was 11.68 ± 5.23. There was no reduction in the score at 2 weeks, remaining at 11.68 ± 5.23 (0% reduction). However, by 4 weeks, the mean SALT score decreased to 10.88 ± 5.0, showing a 6.86% reduction. This improvement continued at 6 weeks, with the score further reducing to 10.45 ± 5.39, corresponding to a 10.53% reduction. These results indicate a gradual improvement over the 6-week period.

Table 5 : Physician Global Assessment Score for Alopecia Areata (n=30)

After 6 weeks of treatment for Alopecia Areata, 61.9% of patients showed poor improvement, while 37.2% experienced good improvement. A small proportion (5.9%) demonstrated very good improvement, and no patients achieved an excellent outcome. Overall, the majority had limited improvement, highlighting the challenge of achieving high efficacy in this condition.

Alopecia Areata is a localized cutaneous inflammatory disorder traditionally managed with steroids and oral methotrexate. Recently, topical methotrexate has become available, expanding treatment options and potentially enhancing the effectiveness of managing localized Alopecia Areata. The alopecia areata group has the highest proportion of male patients, with 66.7% male and 33.3% female. In a study by Darwin E, Hirt PA et al with no difference in incidence between genders.[14]In the present study alopecia predominantly notable , with mean age of 31.57±7.07 present in early adulthood, in a study by Uzuncakmak TK The mean age was 29.86± 14.48 years in AA was observed [15]

In this study The mean duration of alopecia areata in the study was 4.99 ± 8.51 months. In a study by Lim SK et al on low dose MtX The mean disease duration was 29.03±32.61 months the discrpency in study may be due to few localized patches newly diagnosed were taken [16]

In present study Exclusively affects the scalp (93%), consistent with the condition's hallmark of localized hair loss and eyebrows (6%). In a similar study by Darwin et at frequency of involvement of scalp and eyebrow (66.8-95%), 3.8% repectively. 148

1.No Change at 2 Weeks: The mean SALT score remained unchanged at 11.68 ±

5.23 at 2 weeks, indicating that the intervention had not yet shown significant effects at this early time point.

2.Significant Improvement at 4 and 6 Weeks: At 4 weeks, the SALT score decreased to 10.88 ± 5.59, representing a 6.86% reduction from baseline, and at 6 weeks, it further decreased to 10.45 ± 5.39, reflecting a 10.53% reduction. Both reductions were statistically significant (p < 0.05), suggesting that the intervention started to show measurable benefits after 4 weeks and continued to improve at 6 weeks.In a study by Toma dm et al Comparative study between topical methotrexate 1% gel and minoxidil 5% gel in the treatment of localized alopecia areata clinically after 6 weeks, minoxidil showed significantly more excellent improvement than MTX (16% vs. 0%,) after 12 weeks, minoxidil and MTX showed excellent improvement (52 % and 36%) respectively.There was no significant difference in side effects (erythema and itching) between the MTX and minoxidil groups. Both topical MTX 1% gel and topical minoxidil 5% gel had high efficacy in treating localized AA, with no significant differences between them as evaluated by clinical and dermoscopic examination.[17]

This study evaluated the efficacy of topical methotrexate in patients with localized Alopecia Areata over a 6-week period. The findings revealed that the majority of patients were male (66.7%), with a mean age of 27.53±9.78 years. The condition predominantly affected the scalp (93.3%), and all participants had a disease duration of 6 months or less.The SALT score analysis demonstrated no change at 2 weeks but showed a statistically significant reduction at 4 weeks (6.86%) and 6 weeks (10.53%), indicating gradual improvement with continued use of topical methotrexate. Despite this, the Physician Global Assessment revealed that 61.9% of patients had poor improvement, while 37.2% experienced good improvement, and only 5.9% showed very good improvement. No patients achieved an excellent outcome.Compared to other studies, the improvement observed with topical methotrexate was moderate. For example, in a comparative study by Toma DM et al., minoxidil 5% gel showed superior results at 6 weeks. However, both methotrexate and minoxidil demonstrated high efficacy over a longer duration, suggesting that a prolonged treatment period might yield better results.In conclusion, topical methotrexate shows promise as a treatment option for localized Alopecia Areata, with significant improvement observed after 4 weeks. However, the overall effectiveness is moderate, and further studies with extended follow-up and larger sample sizes are warranted to better understand its long-term efficacy and comparative effectiveness against other treatments like minoxidil.

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