Introduction:Chronic plaque psoriasis is a prevalent, immune-mediated inflammatory dermatological condition marked by erythematous, scaly plaques that considerably affect quality of life. Topical corticosteroids are essential in the treatment of mild to moderate psoriasis because of their anti-inflammatory, immunosuppressive, and antiproliferative properties. This study sought to assess the effectiveness and safety of topical corticosteroids in individuals with persistent plaque psoriasis.Methods: A randomized clinical trial was performed on 50 patients diagnosed with persistent plaque psoriasis. Patients were randomly assigned to two groups: Group A (n=25) was administered a high-potency topical corticosteroid (clobetasol propionate 0.05%), whereas Group B (n=25) received a medium-potency corticosteroid (betamethasone valerate 0.1%). The treatment was administered bi-daily for a duration of 8 weeks. The efficacy was evaluated utilizing the Psoriasis Area and Severity Index (PASI) score at baseline, 4 weeks, and 8 weeks. The safety assessment encompassed surveillance for undesirable effects including skin shrinkage, itching, and telangiectasia. Statistical analysis was conducted utilizing suitable methods, with p < 0.05 being significant.Results: The average baseline PASI scores were similar between Group A (12.8 ± 3.2) and Group B (12.5 ± 3.0) (p > 0.05). At 8 weeks, a notable decrease in PASI score was recorded in both groups; however, Group A exhibited a more pronounced drop (3.1 ± 1.2) than Group B (5.4 ± 1.6) (p < 0.001). A PASI-75 response was attained in 18 (72%) patients in Group A and 12 (48%) in Group B. Adverse effects were minor, comprising skin irritation in 4 (16%) patients in Group A and 3 (12%) in Group B, whereas skin atrophy was noted in 2 (8%) patients only in Group A.Conclusion: Topical corticosteroids are efficacious and typically safe for the treatment of persistent plaque psoriasis. Potent corticosteroids had greater efficiency than moderate-potency drugs, however they were linked to a marginally increased occurrence of local side effects. Meticulous oversight and suitable therapy duration are crucial for enhancing outcomes and reducing hazards.
Chronic plaque psoriasis is a prevalent, long-lasting, immune-mediated inflammatory dermatological condition marked by distinct erythematous plaques adorned with silvery scales. It impacts roughly 2–3% of the worldwide population and markedly diminishes patients' quality of life due to its conspicuous form, persistent course, and related symptoms like pruritus, desquamation, and discomfort [1, 2]. The disease originates from multiple factors, including genetic predisposition, environmental triggers, and dysregulation of the immune system, notably with T-cell activation and pro-inflammatory cytokines
[3].
The pathophysiology of psoriasis is intricate and encompasses keratinocyte hyperproliferation, atypical differentiation, and heightened angiogenesis. Essential cytokines, including tumor necrosis factor-alpha (TNF-α), interleukin-17 (IL-17), and interleukin-23 (IL-23), are pivotal in maintaining the inflammatory cascade. Psoriasis, while rarely life-threatening, is linked to several comorbidities such as psoriatic arthritis, metabolic syndrome, and cardiovascular disorders [4-6].
Topical therapy is the primary treatment for mild to moderate persistent plaque psoriasis. Corticosteroids are the most commonly utilized topical medications owing to their powerful anti-inflammatory, immunosuppressive, vasoconstrictive, and antiproliferative characteristics. Corticosteroids of differing potencies are administered based on the severity and location of lesions. Clobetasol propionate (a super-potent corticosteroid) and betamethasone valerate (a moderate-potency corticosteroid) are frequently employed in clinical practice [7].
Although effective, prolonged use of topical corticosteroids may lead to undesirable effects such as skin shrinkage, telangiectasia, striae, and suppression of the hypothalamic-pituitary-adrenal axis, especially with powerful formulations. Thus, it is crucial to equilibrate efficacy and safety while choosing a suitable treatment plan [8].
This randomized clinical trial was conducted to assess and compare the efficacy and safety of potent versus moderate-potency topical corticosteroids in the treatment of chronic plaque psoriasis, in light of the prevalent use of these medications and the necessity for evidence-based potency selection.
A randomized, parallel-group clinical trial was conduted at the Department of Deramatology, Chettinad Hospital and Research Institute, Kelambakkam, Chennai, Tamil Nadu betwwen April 2024 to March 2025. 50 individuals clinically diagnosed with persistent plaque psoriasis were enrolled following the acquisition of signed informed permission. The Institutional Ethics Committee granted ethical permission for the project. Patients were directed to administer the prescribed medication bi-daily to the afflicted regions for a period of 8 weeks. During the trial period, no additional systemic or topical antipsoriatic medications were permitted.
Inclusion Criteria:
Exclusion Criteria:
Statistical Analysis:
Statistical software, such as SPSS, was used for data entry and analysis. Mean ± standard deviation (SD) was used to represent continuous variables, whilst frequencies and percentages were used to portray categorical variables. The paired t-test was used for intra-group comparisons and the independent t-test or chi-square test for inter-group comparisons. It was deemed statistically significant if the p-value was less than 0.0
A total of 50 patients with chronic plaque psoriasis were enrolled and completed the study. Patients were randomized into two groups: Group A (clobetasol propionate 0.05%, n=25) and Group B (betamethasone valerate 0.1%, n=25). The results are presented below.
Table 1: Baseline Demographic and Clinical Characteristics
|
Parameter |
Group A (n=25) |
Group B (n=25) |
p-value |
|
Age (years) |
38.4 ± 10.2 |
36.9 ± 9.8 |
0.58 |
|
Male/Female |
16/9 |
15/10 |
0.77 |
|
Duration of Disease (years) |
5.6 ± 2.3 |
5.2 ± 2.1 |
0.54 |
|
Baseline PASI Score |
12.8 ± 3.2 |
12.5 ± 3.0 |
0.72 |
According to Table 1, there was appropriate randomization and homogeneity between the groups because there was no significant difference in age, gender distribution, disease duration, or baseline PASI scores (p > 0.05).
Table 2: Reduction in PASI Score Over Time
|
Time Point |
Group A (Mean ± SD) |
Group B (Mean ± SD) |
p-value |
|
Baseline |
12.8 ± 3.2 |
12.5 ± 3.0 |
0.72 |
|
4 Weeks |
6.4 ± 2.1 |
8.3 ± 2.4 |
0.01* |
|
8 Weeks |
3.1 ± 1.2 |
5.4 ± 1.6 |
<0.001* |
Table 2 shows that both groups' PASI ratings decreased significantly with time. At both 4 weeks and 8 weeks, Group A demonstrated a noticeably larger decrease than Group B (p < 0.05).
Table 3: PASI-75 Response at 8 Weeks
|
Response |
Group A (n=25) |
Group B (n=25) |
p-value |
|
Achieved PASI-75 |
18 (72%) |
12 (48%) |
0.04* |
|
Not Achieved |
7 (28%) |
13 (52%) |
|
Based on the data in Table 3, it can be concluded that clobetasol propionate is more effective than group B, as 72% of patients in Group A and 48% in Group B respectively attained PASI-75 (p < 0.05).
Table 4: Percentage Reduction in PASI Score
|
Parameter |
Group A (n=25) |
Group B (n=25) |
p-value |
|
Mean % Reduction in PASI |
75.8 ± 8.6 |
56.4 ± 10.2 |
<0.001* |
Table 4 shows that the powerful corticosteroid had a bigger impact on Group A, as indicated by a considerably higher percentage drop in PASI score (p < 0.001) compared to Group B.
Table 5: Adverse Effects Observed
|
Adverse Effect |
Group A (n=25) |
Group B (n=25) |
|
Skin Irritation |
4 (16%) |
3 (12%) |
|
Skin Atrophy |
2 (8%) |
0 (0%) |
|
Telangiectasia |
1 (4%) |
0 (0%) |
|
No Adverse Effects |
18 (72%) |
22 (88%) |
Table 5 indicates that side effects were modest and more frequently observed in Group A. Skin atrophy and telangiectasia were observed exclusively in the powerful corticosteroid group, while the majority of patients in both groups did not encounter any side effect
Chronic plaque psoriasis is a persistent inflammatory skin disorder that markedly impacts patients' quality of life and necessitates appropriate long-term care options. Topical corticosteroids continue to be the primary treatment for mild to severe illness because of their powerful anti-inflammatory and immunosuppressive effects [9, 10].
The current study demonstrated that both treatment groups experienced a significant decrease in PASI scores during the 8-week treatment period, hence validating the efficacy of topical corticosteroids in the management of chronic plaque psoriasis. The reduction was markedly larger in the clobetasol propionate group (Group A) than in the betamethasone valerate group (Group B), demonstrating the superior efficacy of the powerful corticosteroid [11, 12].
The current investigation revealed that baseline variables, including age, gender distribution, disease duration, and first PASI scores, were equivalent between the two groups (p > 0.05), indicating effective randomization and mitigating selection bias. This enhances the credibility of the observed results [13, 14].
In this trial, 72% of patients in Group A attained PASI-75, whereas 48% in Group B did, indicating a markedly superior clinical response to clobetasol propionate. Prior research has repeatedly demonstrated that powerful topical corticosteroids exhibit superior efficacy and expedited clearance of psoriatic lesions relative to moderate-potency treatments, corroborating the findings of the current investigation [15-17].
The current investigation revealed a considerably greater mean percentage reduction in PASI score for Group A (75.8 ± 8.6%) compared to Group B (56.4 ± 10.2%), hence reinforcing the enhanced therapeutic efficacy of the powerful corticosteroid. Previous research have indicated that higher potency corticosteroids exhibit enhanced anti-inflammatory effects and have improved clinical outcomes [18, 19].
The current investigation revealed that side effects were minor and more prevalent in the powerful corticosteroid group, comprising skin irritation (16%), skin atrophy (8%), and telangiectasia (4%). The moderate-potency group exhibited a reduced incidence of adverse effects. Prior research indicates that extended use of high-potency corticosteroids correlates with local deleterious effects, including skin atrophy and telangiectasia, underscoring the necessity for prudent application [20, 21].
The action of topical corticosteroids entails the inhibition of inflammatory cytokines, reduction of keratinocyte growth, and vasoconstriction, resulting in the enhancement of psoriatic lesions. The potency of corticosteroids directly affects their efficacy and the likelihood of side effects [22].
In the current trial, the majority of patients exhibited good tolerance to the medication, with most reporting no notable ill effects. This indicates that the short-term application of topical corticosteroids is comparatively safe when administered under physician oversight [23].
Notwithstanding the encouraging results, the study possesses specific limitations, such as a comparatively small sample size and a brief follow-up period. The evaluation did not include long-term safety and recurrence rates, which are critical factors in chronic conditions such as psoriasis [24, 25].,
Results from this study demonstrate that betamethasone valerate and clobetasol propionate, two topical corticosteroids, significantly reduce the severity of persistent plaque psoriasis. A stronger reduction in PASI scores and higher PASI-75 response rates were seen by the powerful corticosteroid clobetasol propionate, though. Skin atrophy and irritation were moderate and controllable local side effects, however they were significantly more common with the powerful corticosteroid. Thus, when taken under close physician supervision, powerful topical corticosteroids can be a better choice for short-term treatment. The selection of topical corticosteroids must strike a balance between safety and efficacy. Achieving optimal therapeutic outcomes while limiting unwanted effects requires individualized treatment regimens and regular monitoring.
Funding
None
Conflict of Interest:
None