Psoriasis is a chronic, immune-mediated dermatological condition marked by erythematous, scaly plaques and is increasingly recognized in the pediatric population, affecting approximately 0.5–2% of children globally (1). The disease not only impacts the physical well-being of affected children but also exerts a significant psychological burden on patients and caregivers (2). Among the clinical variants, plaque-type psoriasis is the most commonly observed form in children, necessitating early and sustained intervention to minimize flares and long-term complications (3).

Topical corticosteroids remain the cornerstone of treatment for mild to moderate pediatric psoriasis due to their potent anti-inflammatory and immunosuppressive actions (4). However, prolonged use, particularly in sensitive pediatric skin, has been associated with adverse effects such as cutaneous atrophy, telangiectasia, and hypothalamic-pituitary-adrenal axis suppression (5). These safety concerns have led to growing interest in steroid-sparing alternatives for long-term management.

Calcineurin inhibitors, such as tacrolimus and pimecrolimus, have demonstrated efficacy in various inflammatory skin diseases and are approved for atopic dermatitis in children (6). Their off-label use in psoriasis has shown promise, particularly for facial, intertriginous, and other steroid-sensitive areas (7). These agents inhibit T-cell activation and cytokine production without causing skin thinning, making them appealing for pediatric use (8).

Despite emerging evidence, direct comparisons of topical corticosteroids and calcineurin inhibitors in pediatric psoriasis remain limited. Therefore, this randomized controlled trial was designed to evaluate and compare the clinical efficacy and safety of topical corticosteroids versus calcineurin inhibitors in children with plaque-type psoriasis.

A randomized, open-label, parallel-group controlled trial was conducted over a period of 12 weeks in the Pediatric Dermatology Department of a tertiary care hospital. Ethical clearance was obtained from the institutional ethics committee prior to study initiation, and written informed consent was taken from all participants’ guardians.

Study Participants:

Children aged between 5 and 16 years with a clinical diagnosis of mild to moderate plaque psoriasis, defined by a Psoriasis Area and Severity Index (PASI) score between 5 and 12, were enrolled. Exclusion criteria included pustular or erythrodermic psoriasis, recent systemic or topical treatment within the last 4 weeks, any known immunosuppressive condition, or hypersensitivity to study medications.

Randomization and Group Allocation:
A total of 60 eligible patients were randomly assigned into two groups (n=30 each) using a computer-generated randomization list.

• Group A received topical 0.05% betamethasone dipropionate ointment applied once daily.
• Group B received topical 0.1% tacrolimus ointment applied twice daily.

Patients and caregivers were instructed on correct application techniques and advised to avoid using any other topical or systemic treatments during the trial period.

Clinical Evaluation:

Participants were evaluated at baseline, 6 weeks, and 12 weeks. PASI scores were recorded at each visit by a blinded dermatologist. The percentage reduction in PASI score from baseline was used to assess treatment efficacy. Adverse effects such as burning sensation, pruritus, or skin thinning were documented at each follow-up.

Statistical Analysis:

Data were compiled and analyzed using SPSS version 26. Continuous variables such as PASI scores were expressed as mean ± standard deviation and compared using paired and unpaired t-tests. Categorical variables like adverse events were analyzed using chi-square tests. A p-value < 0.05 was considered statistically significant.

A total of 60 pediatric patients were enrolled in the study and completed the trial. The demographic characteristics of the participants were comparable between the two groups. The mean age of patients in Group A (topical corticosteroids) was 10.2 ± 2.8 years, and in Group B (calcineurin inhibitors) it was 10.6 ± 3.1 years. The gender distribution was nearly equal in both groups.

Efficacy Analysis

At baseline, the mean PASI score was 10.2 ± 1.4 in Group A and 9.8 ± 1.7 in Group B. At 12 weeks, Group A exhibited a mean PASI score reduction to 3.2 ± 0.8, while Group B showed a reduction to 3.6 ± 0.9. The percentage reduction in PASI was 68.3% in Group A and 63.5% in Group B. The difference in PASI reduction between the two groups was not statistically significant (p = 0.214), indicating comparable efficacy (Table 1).

Safety and Tolerability

Adverse events were reported in both groups, with notable differences. Skin thinning occurred in 6 (20%) patients in Group A but was absent in Group B. In contrast, 8 (26.7%) patients in Group B reported transient burning sensation during the first week of application, which resolved spontaneously. Pruritus was noted in 3 (10%) patients in Group A and 2 (6.7%) in Group B (Table 2).

Table 1. Comparison of PASI Scores Between Groups A and B at Different Time Points

Table 2. Adverse Effects Observed in Group A and Group B

The treatment response was evident in both groups by week 6 and continued to improve until week 12. Although corticosteroids showed a slightly greater reduction in PASI scores, calcineurin inhibitors were better tolerated, especially for long-term use in steroid-sensitive areas.

Psoriasis in children poses a unique therapeutic challenge due to its chronic nature, sensitivity of pediatric skin, and long-term safety concerns associated with conventional treatments (1). The findings of our randomized controlled trial suggest that both topical corticosteroids and calcineurin inhibitors are effective in managing mild to moderate pediatric plaque psoriasis, with comparable efficacy but differing safety profiles.

Topical corticosteroids remain the first-line therapy owing to their rapid anti-inflammatory and immunosuppressive actions (2). Our study demonstrated a 68.3% reduction in PASI scores over 12 weeks in the corticosteroid group, aligning with previous literature reporting improvements ranging from 60–75% in similar populations (3,4). However, consistent with existing evidence, prolonged use was associated with adverse effects such as skin thinning, observed in 20% of patients in our cohort (5,6). These findings underscore the limitations of long-term corticosteroid use, particularly in areas with thinner skin such as the face or intertriginous zones (7).

Calcineurin inhibitors, primarily tacrolimus and pimecrolimus, offer an alternative therapeutic approach with a more favorable safety profile. In our study, the calcineurin inhibitor group exhibited a 63.5% reduction in PASI scores, comparable to that seen with corticosteroids. Previous studies have demonstrated the efficacy of tacrolimus in pediatric patients, particularly for facial and flexural psoriasis, where corticosteroids may pose higher risks (8,9). While transient burning sensation was reported in 26.7% of patients in our study, this side effect was mild and self-limiting, in accordance with earlier trials (10,11).

Several comparative studies have shown that calcineurin inhibitors, although slightly less potent than high-potency steroids, maintain disease control with significantly fewer side effects, making them suitable for long-term use in sensitive areas (12,13). Our findings support this perspective, as no patients in the tacrolimus group experienced cutaneous atrophy, a common concern with topical corticosteroids (14).

Furthermore, the psychosocial impact of psoriasis in children should not be overlooked. Safe and effective long-term management is crucial not only to reduce flares but also to improve the quality of life and reduce stigma associated with visible lesions (15). Calcineurin inhibitors, given their safety, may help address these concerns by allowing for continuous use without fear of systemic or local toxicity.

In conclusion, both corticosteroids and calcineurin inhibitors are effective in controlling mild to moderate pediatric psoriasis. However, given the reduced risk of adverse effects, calcineurin inhibitors may be preferable for long-term management, especially for steroid-sensitive areas.

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