Psoriasis is a papulosquamous condition characterised by diverse form, location, severity, and progression. It is located at characteristic areas of distinct, erythematous, indurated papules and plaques, encircled by extensive, loose, silvery scales [1]. The global prevalence is approximately 2%. The incidence of psoriasis in India varies between 0.44% and 2.8%. While psoriasis can manifest at any age, the peak incidence occurs in those between 20 to 39 years. It is twice as prevalent in males as in females. The majority of patients appear in their third or fourth decade of life [2]. Psoriasis is categorised according to its start, progression, and morphology as chronic plaque psoriasis, guttate psoriasis, pustular psoriasis, inverse psoriasis, and erythrodermic psoriasis. Chronic plaque psoriasis, known as psoriasis vulgaris, is the predominant kind of psoriasis. The typical clinical signs consist of well-defined, erythematous, itchy plaques adorned with silvery scales. The lesions are bilateral and symmetrical at pressure locations, including the elbows, knees, extensors, scalp, and trunk. The palms and soles are often affected as well.
The current topical treatments for mild to moderate chronic plaque psoriasis include local corticosteroids, coal tar, dithranol, tazarotene, calcipotriol, tapinarof, and calcineurin inhibitors such as tacrolimus and pimecrolimus. Nonetheless, each preparation possesses its drawbacks. Topical drugs may induce cutaneous atrophy, tachyphylaxis, perilesional hypopigmentation, and premature relapse. Coal tar is more unrefined, darker, more cumbersome to utilise. It may also induce chemical folliculitis and irritating contact dermatitis, and functions in conjunction with light therapy. Dithranol is an irritant that discolours clothing and adjacent skin, and it is also effective in conjunction with light therapy. Tazarotene is not commonly utilised in persistent plaque psoriasis; it is an irritant and contraindicated during pregnancy. Tapinarof has recently received approval and is currently unavailable in India. Tacrolimus and pimecrolimus are designated for face lesions. Calcipotriol, or calcipotriene, is a synthetic derivative of calcitriol, the active form of vitamin D. It is accessible in topical formulation for dermatological application. Calcipotriol is mostly utilised in the treatment of chronic plaque psoriasis in mild to moderate cases. Calcipotriol suppresses epidermal cell proliferation and promotes cell differentiation. Calcipotriol is a primary treatment for mild to moderate psoriasis, either as monotherapy or in conjunction with another anti-psoriatic agent. It is administered bi-daily, demonstrating efficacy and safety in the treatment of psoriasis. Clinical enhancement of psoriatic lesions transpires about two weeks, with optimal improvements noted between four to eight weeks. It is utilised as a 0.005% (50 mcg/gram) ointment or cream. Research indicates that calcipotriol possesses an exceptional safety profile. Adverse responses are modest, including skin irritation (lesional and perilesional), pruritus, burning feeling, erythema, and scaling. Calcipotriol is contraindicated for facial application [6]. Methotrexate is a folic acid antagonist exhibiting cytotoxic and immunosuppressive properties. It is utilised in several illnesses such as cancer treatment, rheumatoid arthritis, Crohn's disease, and ectopic pregnancy. Methotrexate is often administered orally. Topical formulations are now available for dermatological applications [7]. It is actively absorbed by cells via the folate transport system and is metabolised into polyglutamate derivatives. These polyglutamate compounds persist within the cells for weeks and months, even in the absence of an external medication [8]. Methotrexate yields significant outcomes in psoriasis when administered systemically. Topical formulations are recommended for localised psoriasis, as they do not entail the adverse effects associated with systemic treatments. Topical methotrexate functions by locally inhibiting DNA synthesis in the hyperplastic epidermis associated with psoriasis [9]. Clinical enhancements were noted in the majority of patients following an eight-week regimen with bi-daily treatment [10]. The predominant adverse responses associated with topical methotrexate include a burning sensation, irritation, itching, and erythema.

Study Design:

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

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 psoriasis 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 psoriasis were included in the study.

Inclusion Criteria:

• Patients clinically diagnosed with psoriasis.
• 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.
• Psoriasis Area Severity Index (PASI) 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 PASI scores were analyzed using paired t-tests, with a p-value < 0.05 considered statistically significant.

Table 1: Baseline Demographics for Psoriasis (n=30)

In a study of 30 patients with psoriasis, 36.7% were male and 63.3% were female. The majority of patients were aged between 31-40 years (53.3%), followed by 21-30 years (36.7%), with a mean age of 31.57 ± 7.07 years. Regarding the duration of the disease, 56.7% had psoriasis for 6 months or less, 16.7% for 7-12 months, and 26.7% for more than 12 months, with a mean duration of 9.78 ± 10.86 months. In terms of the affected sites, 40.0% had lesions on both palms and soles, 30.0% on the palms, and 30.0% on the soles. No involvement was observed on the scalp, wrists, ankles, or eyebrows.

Table 2: Distribution According to Occupation for Psoriasis Patients (n=30)

In a study of 30 psoriasis patients, the most common occupation was students (26.7%), followed by housewives (20.0%). Other notable groups included farmers, private job holders, and teachers, each comprising 10.0% of the participants. Labourers accounted for 6.7%, while smaller proportions were observed among drivers, engineers, lawyers, shopkeepers, and unemployed individuals, each representing 3.3%. This distribution shows that psoriasis affects individuals across a diverse range of occupational backgrounds.

Table3 ESI change from baseline at 2, 4 and 6 weeks in Psoriasis group

All comparisons done from baseline

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

The above table shows the ESI change from baseline at 2, 4 and 6 weeks in psoriasis group.

The mean ESI at baseline in psoriasis group was 4.97 ± 1.03; at 2 weeks, it was

4.33 ± 1.07; at 4 weeks, it was 3.67 ± 1.39 and at 6 weeks, it was 3.50 ± 1.41.

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

Table 4 Mean percentage reduction of psoriasis

At baseline, the mean ESI score for psoriasis patients was 4.97 ± 1.03. After 2 weeks, the score decreased to 4.33 ± 1.07, reflecting a 12.89% reduction. By 4 weeks, the mean ESI further dropped to 3.67 ± 1.39, showing a 26.16% reduction. At 6 weeks, the score reached 3.50 ± 1.41, indicating a total reduction of 29.16%. These findings demonstrate a gradual and consistent improvement in ESI scores over the 6-week treatment period.

Table5: Physician Global Assessment Score for Psoriasis After 6 Weeks (n=30)

After 6 weeks of treatment for psoriasis, 47.1% of patients showed very good improvement, while 34.9% experienced good improvement. A smaller proportion (14.3%) had poor improvement, and 44.4% achieved excellent results. Overall, the majority of patients responded positively to the treatment, with significant improvement observed in most cases.

The majority of patients in the study are female, with 63.3% being female and 36.7% male. However, Varma SK et al (2017)[11]and Ramani RY et al (2016)[12] documented slight male preponderance. The observed discrepancy between this study and our study could be due to difference in health seeking behavior of males and females. Females especially of younger age group seek medical care due to cosmetic reasons.

The age distribution highlights that Psoriasis generally affects older individuals, with a mean age of 31.57 years). The majority of Psoriasis patients fall within the 31-40 age group (53.3%), similiarly In present study, majority of patients with psoriasis irrespective of type of psoriasis belonged to 21 to 30 years of age (27.7%) and mean age of presentation was 36.8±13.92 (Range 18 to 75) years. In a study by Varma SK et al (2017), mean age of patients of psoriasis was 42.48±12.29 years.[11] However, mean age of patients with psoriasis was 39.57±10.04 years in a study by Ramani RY et al (2016) 146 which was similar to present study.[12]

In present study The mean duration of psoriasis in the study was 9.78 ± 10.86 months. Mean duration of palmoplantar psoriasis in a study by Kumar B et al (2004) 145 in patients managed using methotrexate gel was 3 yrs (2 mos–15 yrs).

Primarily affects the palms (30%), soles (30%), and both palms and soles (40%). This indicates a tendency for Psoriasis to manifest on thicker skin areas. present study, both palms and soles were involved in majority of patients in two treatment arms. These findings were supported by finding of Kumar B et al (2004) in which both palm and soles were most commonly involved. [13]

The mean ESI scores significantly decreased from baseline (4.97 ± 1.03) to 2 weeks (4.33 ± 1.07), 4 weeks (3.67 ± 1.39), and 6 weeks (3.50 ± 1.41). All of these changes were statistically significant, with p-values ≤ 0.001, suggesting that the observed improvements are unlikely to be due to chance.

The results show significant improvements in Erythema, Scaling, and Induration (ESI) over time:

1. 2 weeks: ESI reduced by 12.89% (from 4.97 to 4.33), indicating early therapeutic The p-value of 0.001 confirms statistical significance.

2. 4 weeks: The reduction increased to 16% (mean 3.67), showing continued effectiveness.

3. 6 weeks: ESI scores further improved by 60% (mean 3.50), suggesting sustained benefits

However, Kumar B et al (2004) reported complete clearance of lesions in none of the patients with palmoplantar psoriasis following 0.25% methotrexate gel preparations. [13]Ravi Kumar BC et al (1999) in their study observed complete clearance of plantar lesion in 42.8% patients following topical methotrexate therapy.[14]

This study demonstrates that 1% methotrexate gel is an effective topical treatment for psoriasis, particularly for lesions on the palms and soles. Over a 6-week period, significant improvements were observed in Erythema, Scaling, and Induration (ESI) scores, with a reduction of 29.16% from baseline. The Physician Global Assessment showed that 47.1% of patients achieved very good improvement, and 44.4% reached excellent results. These findings indicate that topical methotrexate gel provides a promising, non-invasive alternative to systemic therapies for localized psoriasis, with consistent and statistically significant benefits. Further studies with larger sample sizes and longer follow-up periods are recommended to confirm these results and evaluate long-term efficacy and safety.

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