Lichen planus (LP) is an idiopathic inflammatory condition characterized by a recurring and remitting trajectory. The disease is frequently circumscribed and resolves with topical treatment; nevertheless, severe and resistant lesions may occur in up to 20% of individuals [1]. A meta-analysis of therapies for LP, which examined 21 distinct therapy modalities, indicated low or very low quality of evidence for all systemic medications except oral steroids [2].
Oral corticosteroids (OCS) are frequently administered for moderate to severe cutaneous lichen planus; nevertheless, recurrent episodes are commonly observed post-therapy cessation, and unpleasant effects associated with steroids regularly arise. The latter are often observed in conjunction with long-acting steroids as a component of "oral mini pulse" [3]. Additional pharmacological options for the treatment of extensive lichen planus encompass metronidazole, acitretin, cyclosporine, thalidomide, leflunomide, griseofulvin, sulfasalazine, enoxaparin, methotrexate, dapsone, mycophenolate mofetil, azathioprine, phototherapy, and more recently, JAK inhibitors; however, the majority possess limited and low-level supporting evidence.
Methotrexate (MTX) exerts a substantial inhibitory effect on lymphoid cells [8]. In an open trial, four patients with severe erosive lichen planus were administered a combination of methotrexate (10-15 mg/week) and topical corticosteroids for 17 months, demonstrating safety and efficacy for the condition [9]. Our aim was to evaluate the efficacy of 1% methotrexate gel in patients with lichen planus.

Study Design:

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

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 complaints of lichen planus 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 lichen planus were included in the study.

Inclusion Criteria:

• Patients clinically diagnosed with lichen planus.
• 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.
• Patients were advised not to use any other topical or oral medications during the study period.
• Lichen Planus Area Severity Index (LPASI) was assessed at 2-week intervals at baseline (0), 2, 4, and 6 weeks to evaluate the severity and improvement of lesions.
• 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 LPASI scores were analyzed using paired t-tests, with a p-value < 0.05 considered statistically significant.

Table 1: Baseline Demographics of Patients with Lichen Planus

In a study of 30 patients with lichen planus, 60% were female and 40% were male. The age distribution showed that 33.3% were between 11-20 years, 36.7% between 21-30 years, and 30% between 31-40 years, with no patients above 40. The mean age was 25.97±8.06 years. Most patients (93.3%) had the disease for ≤6 months, while 3.3% each had it for 7-12 months or more than 12 months, with an average disease duration of 5.91±6.58 months. The wrist was the most common site affected (63.3%), followed by the ankle (33.3%), and palms (3.3%), with no cases on the scalp or soles.

Table 2: Distribution According to Occupation (Lichen Planus, n=30)

This table shows the occupational distribution of 30 lichen planus patients, with the highest percentage being students (26.7%) and housewives (23.3%).

Table.3 : Lichen Planus Severity Score change from baseline at 2, 4 and 6 weeks in Lichen Planus group

All comparisons done from baseline

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

The above table shows the Lichen Planus Severity Score change from baseline at 2, 4 and 6 weeks in Lichen Planus group.

The mean Lichen Planus Severity Score at baseline in psoriasis group was 8.20 ± 2.99; at 2 weeks, it was 7.83 ± 3.12; at 4 weeks, it was 7.27 ± 3.24 and at 6 weeks,

it was 6.97 ± 3.21.

There was a persistent significant reduction in the mean Lichen Planus Severity Score at 2 weeks, 4 weeks and 6 weeks compared to baseline (P<0.05).

Table4 : Physician Global Assessment Score for Lichen Planus after 6 Weeks

• Chi-square test value = 10.036
• p-value = 0.004 (Significant)

This table shows the distribution of physician global assessment scores for lichen planus patients after 6 weeks, indicating a significant improvement (p=0.004).

Localized cutaneous inflammatory disorder like, psoriasis, lichen planus, alopecia areata in which we used to give steroids and oral methotrexate. Now methotrexate is available in topical form to widen the treatment modality and effectiveness of topical methotrexate in localized skin disorder. In the lichen planus group, there are a slightly higher proportion of male patients compared to female patients, with 66.7% male and 33.3% female. In a study by Gorouhi F et al [10] , No sexual predilection is evident but some reports indicate a slight predominance in women up to a ratio of 2 : 1. Similarly in a study by kyriakis et al [11] no specific gender predominance has been recognized, LP may affect more adult females than adult male. Lichen Planus affects individuals predominantly in their twenties, although it also manifests in significant numbers among those aged 11-20 and 31-40, at 33.3% and 30.0%, respectively. In a study by Madhumita Bhattacharya et al LP affects patients of all ages, but up to 95% of all cases occur in adults, with most patients presenting between the third and fourth decades of life. [12] The mean duration of lichen planus in this study was 5.91 ± 6.58 months in a study by Hakan turan et al oral MtX in lichen planus mean duration of lichen planus was 6.3 months (range 2-24mos ) [13] Predominantly affects the wrists (63.3%) and ankles (33.3%), which are common sites for this condition, reflecting its characteristic presentation in areas of friction. In a similar study by Madhumita Bhattacharya et al limbs were the most frequent initial site of onset (55.6%) [14]

Lichen Planus Severity Score (LPSS) changes over 2, 4, and 6 weeks in the Lichen Planus group, showing significant improvements in lesion severity with the intervention.

1. Initial Improvement at 2 Weeks: The mean LPSS at baseline was 20 ± 2.99 and decreased to 7.83 ± 3.12 at 2 weeks, reflecting a 4.51% reduction. This early reduction was statistically significant (p = 0.001), suggesting an initial therapeutic effect.
2. Sustained Improvement at 4 Weeks: At 4 weeks, the LPSS further decreased to 27 ± 3.24, indicating an 11.34% reduction from baseline. This sustained improvement was also statistically significant (p = 0.001), showing that the intervention continued to have a positive effect on lesion severity.
3. Continued Improvement at 6 Weeks: By 6 weeks, the LPSS reached 97 ± 3.21, with a 15.0% reduction from baseline, demonstrating continued effectiveness of the intervention over time.

However there are no significant studies however in a study by Saima Ilyas et al oral methotrexate MTX proved efficacious in 63.6% of patients of LP as there was more than 50% reduction in number of lesions.

The drug is effective in cutaneous LP. Similarly in study by A.J. Kanwar et al [15] oral methotrexate in lichen planus After 2 weeks of treatment, seven patients (30%) had at least improvement by the end of 14 weeks was 79%.

This prospective cross-sectional study evaluated the efficacy of 1% methotrexate gel in treating lichen planus over a 6-week period. The study demonstrated a significant and consistent reduction in the Lichen Planus Severity Score at 2, 4, and 6 weeks compared to baseline, with p-values < 0.05 at all time points. Additionally, the Physician Global Assessment Score showed a notable improvement, with 47.1% of patients achieving a "Very Good" outcome and 55.6% achieving an "Excellent" outcome, further confirming the efficacy of methotrexate gel in managing lichen planus.

The study highlighted that the highest incidence was among students and housewives, predominantly affecting females (60%) more than males (40%). The most commonly affected site was the wrist (63.3%), followed by the ankle (33.3%).

Overall, 1% methotrexate gel was found to be an effective topical treatment option for lichen planus, showing significant clinical improvement without the need for systemic therapy. However, further studies with larger sample sizes and long-term follow-up are recommended to validate these findings and assess the long-term safety and efficacy of methotrexate gel for lichen planus.

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