|Year : 2018 | Volume
| Issue : 2 | Page : 86-92
Comparison of efficacy, safety, and cost-effectiveness of topical salicylic acid 6% versus clobetasol propionate 0.05% in the treatment of limited chronic plaque psoriasis
Narayana Goruntla1, Govardhan Kumar Arakala1, Gowthami Priyanka Nelluri1, K Naga Mounika1, Srinivas Pujari2, Manoj Kumar Byalla3
1 Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education and Research, Anantapur, Andhra Pradesh, India
2 Department of Dermatology, Government General Hospital, Anantapur, Andhra Pradesh, India
3 Department of Pharmaceutical Sciences, JNTUA, Anantapur, Andhra Pradesh, India
|Date of Submission||14-Jan-2018|
|Date of Acceptance||20-Mar-2018|
|Date of Web Publication||13-Aug-2018|
Mr. Narayana Goruntla
Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education and Research, K.R. Palli Cross, Anantapur - 515 721, Andhra Pradesh
Source of Support: None, Conflict of Interest: None
Aims: The aims of this study were to: (1) Comparison of Psoriasis Area Severity Index (PASI), Physician Global Assessment (PGA) Scores, and adverse effect profile on the use of topical salicylic acid 6% versus clobetasol propionate 0.05% in the chronic-limited plaque psoriasis.(2) Selection of the cost-effectiveness option using average cost-effective ratios of the two individual regimens. Materials and Methods: This was a randomized, open-labeled, parallel group design which was conducted at dermatology department of a tertiary care hospital located in resource-limited settings of South India. A total of 75 patients were recruited and randomized into two groups: Group A received 6% of topical salicylic acid and Group B received 0.05% of clobetasol propionate for 3 months with a three follow-up visits. Efficacy was assessed based on the reduction of PASI and PGA scores at each visit. The safety profile of two drugs was assessed by a screening of adverse drug reactions. Cost-effectiveness of treatment groups was calculated by considering inputs of direct medical costs required to reduce one unit on PGA scale. Results: Demographic and clinical profiles of participants were matched between two groups. The mean PASI score of Group A and Group B were reduced from baseline (4.36, 4.67) to final follow-up (1.97, 2.03). There was a statistically significant difference exist in mean PASI score difference of Group A and Group B from baseline to 1st follow-up and baseline to 2nd follow-up (P < 0.00001) visits. Whereas, at final follow-up, mean PASI score difference of two groups was almost equal (P < 0.21). Conclusion: Initially, clobetasol propionate shows more effective compared to salicylic acid in the reduction of PASI score. But at end of the treatment, both drugs were equal in the reduction of PASI score where only matters the cost. Salicylic acid was a cost-effectiveness option in limited chronic plaque psoriasis.
Keywords: Chronic plaque psoriasis, clobetasol propionate, cost-effectiveness, salicylic acid
|How to cite this article:|
Goruntla N, Arakala GK, Nelluri GP, Mounika K N, Pujari S, Byalla MK. Comparison of efficacy, safety, and cost-effectiveness of topical salicylic acid 6% versus clobetasol propionate 0.05% in the treatment of limited chronic plaque psoriasis. J Health Res Rev 2018;5:86-92
|How to cite this URL:|
Goruntla N, Arakala GK, Nelluri GP, Mounika K N, Pujari S, Byalla MK. Comparison of efficacy, safety, and cost-effectiveness of topical salicylic acid 6% versus clobetasol propionate 0.05% in the treatment of limited chronic plaque psoriasis. J Health Res Rev [serial online] 2018 [cited 2019 Mar 23];5:86-92. Available from: http://www.jhrr.org/text.asp?2018/5/2/86/238863
| Introduction|| |
Psoriasis was a noncommunicable, chronic, immune-mediated, inflammatory skin disorder which affects approximately 1%–3% of world population. About 80%–90% of patients with psoriasis will have plaque form of the disease which was called as psoriasis vulgaris. Psoriasis was characterized by well-circumscribed, scaly erythematous plaques due to infiltration of inflammatory T-cells producing cytokines in skin lesions. Psoriasis most frequently affects the skin of the elbows, knees, scalp, lumbosacral areas, intergluteal cleft, glans penis, and nails which will have a significant negative impact on the quality of life. Even there was no cure for psoriasis, but it will be effectively controlled by various therapeutic options used alone or in combination. The rate of clearance success was high in the initial phase of treatment, but in long-term, maintenance phase was uncertain. Depending on the disease severity level, various treatment strategies were available to control psoriasis-like topical therapy, phototherapy, and systemic therapy which will be used alone or in combination.
Majority of the patients with psoriasis have limited disease affecting only a small body surface area (BSA). Topical treatment option was most preferred to treat psoriasis affecting <10% of total BSA. Salicylic acid was one of the oldest topical preparations which having high efficacy and safety profile in the treatment of limited plaque psoriasis. Topical salicylic acid acts by its keratolytic, bacteriostatic, and fungicidal properties in control of plaque psoriasis.
Topical corticosteroids were the mainstay for first-line treatment of psoriasis in single or combination with other agents. Clobetasol propionate 0.05% exert anti-inflammatory, antiproliferative, and immunosuppressive action by stimulation of phospholipase A2 inhibitory proteins, which will be used in the treatment of limited plaque psoriasis.
Very few studies were conducted on topical modalities in psoriasis in Indian population. There was a lack of evidence on topical modalities like salicylic acid 6% compared with clobetasol propionate 0.05% in the management of limited plaque psoriasis in Indian population. Hence, this study aims to compare efficacy, safety, and cost-effectiveness of topical salicylic acid 6% versus clobetasol propionate 0.05% in the treatment of limited chronic plaque psoriasis.
| Materials and Methods|| |
This was a prospective, randomized, open-labeled comparative study conducted at the OutPatient Dermatology Department of Tertiary care hospital, Anantapur District, Andhra Pradesh, India, from December 2016 to May 2017. The study was approved by the Institutional Review Board (IRB) with a number of RIPER/IRB/2017/007. Patients who were clinically diagnosed with chronic limited plaque psoriasis with <10% body involvement and taking treatment outpatient basis were included in this study. Patients who were on systemic therapy for psoriasis or any other treatment which can alter results for the last 4 weeks, pregnant and breastfeeding women, unstable psoriasis, and other skin infections coming to Dermatology OutPatient Department were excluded from the study. Patients who fulfilling the study criteria were recruited for the study. Written informed consent was obtained from each patient.
A total of 75 patients were randomized into two groups (Group A and Group B). Group A (n = 35) received topical salicylic acid 6% every night and Group B (n = 40) received topical clobetasol propionate 0.05% every night for 3 months with three follow-up visits on 4th, 8th, and 12th week. A suitable prevalidated data collection form [Annexure 1] was used to collect baseline demographic profile such as age, gender and clinical profile such as redness, thickening, and scaling on 0–4 point scale.
Efficacy of two treatment options were assessed by a comparison of mean Psoriasis Area Severity Index (PASI) score, difference in mean PASI score, mean Physician Global Assessment (PGA) score, difference in mean PGA score at each follow-up visits, and proportion of patients achieving PASI 50 and PASI 75 at week 12 or end point of treatment. Other treatment outcomes such as complete clearance, responders, poor responders, deterioration, and relapse were also measured in two groups.
PASI was an index used to express the severity of psoriasis. It combines percentage of area affected (<10%) and severity level of erythema (redness), induration (thickness), and desquamation (scaling). The severity level will be graded between 0 and 4, where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very severe will be used to calculate by PASI calculator as shown in [Figure 1], Annexure 1. Mean PASI score and mean difference of PASI score were compared at each follow-up visits.
PGA scale consists of scoring from 0 to 4, where 0 = Clear (No signs of psoriasis, but postinflammatory discoloration), 1 = Almost clear (only minimal plaque elevation, scaling, and erythema will present), 2 = Mild (slight plaque elevation, scaling, erythema), 3 = Moderate (moderate plaque elevation, scaling, and erythema), and 4 = Severe (very marked plaque elevation, scaling, and erythema). The physician gives the scoring based on the symptoms present in the patient. Mean PGA score and a mean difference of PGA score were compared at each follow-up visits.
Other treatment outcomes such as “PASI 50” a 50% reduction in PASI, “PASI 75” a 75% reduction in PASI, “Complete clearance” attainment of PASI score 0 at any point of time during treatment period, “Responders” attainment of PASI <50 at end point of treatment, “Poor responders” attainment of PASI >50 at end of treatment, “Deterioration” increase in PASI from baseline at any time during 12 weeks of treatment, “Relapse” recurrence of disease in treatment phase after attaining PASI score 0 and stopping treatment, and “Loss to follow-up” any patient who did not return for follow-up visits after the initiation of treatment were measured in both the groups. The safety of both drugs was monitored by identification of adverse drug reactions during complete course of study.
Finally, cost-effectiveness analysis was performed by taking medication costs incurred by the patient for a complete course of therapy and reduction in PGA score as an effectiveness parameter. The medication costs made by patients were measured by multiplying a number of tubes consumed for the course of therapy and one tube cost. The difference in PGA score from baseline to final follow-up will be considered as a reduction in PGA score. Finally, mean costs and mean reduction in PGA scores were determined. The mean cost-effectiveness ratio was calculated by dividing mean costs with a mean reduction of effectiveness. This value indicates the amount of money required to reduce one unit of PGA score.
GraphPad Prism version 6.04 software (La Jolla, California, USA), was used to analyze collected data from all participants. Descriptive statistics such as mean, standard deviation, frequency, and proportion were used to represent baseline demographic and clinical profile of the patients. Two-sample Wilcoxon rank-sum (Mann–Whitney) was used to compare the mean difference of PASI score and PGA score between two groups at each follow-up visits. P < 0.05 was considered statistically significant.
| Results|| |
A total of 75 patients were enrolled into the study and randomized into Group A (n = 35) to receive Salicylic acid 6% and Group B (n = 40) to receive Clobetasol propionate 0.05% every night for 3 months. After trial completion, about three patients from Group A and four patients from Group B were withdrawn from the study. The mean age of the study participants in Group A (37.17 ± 11.38) and Group B (34.9 ± 9.93), majority in Group A (23; 71.87%) and Group B (26; 72.22) were belonging to male gender, baseline mean score of redness, thickening, and scaling in Group A (2.52 ± 0.89, 2.44 ± 1.02 and 3.47 ± 0.67) and Group B (1.69 ± 0.79, 1.92 ± 0.92 and 3.38 ± 0.72) as shown in [Table 1].
At baseline, mean PASI score was almost equal in Group A (4.36) and Group B (4.67), whereas the score was well declined in Group B (2.89, 2.38) compared to Group A (3.94, 3.06) in 2nd and 3rd (final) follow-up visits. At the final follow-up visit, both groups attained almost equal mean PASI score in Group A (1.97) and Group B (2.03) as shown in [Table 2].
|Table 2: Distribution of Psoriasis Area Severity Index and Physician Global Assessment scores in two groups at each follow-up visit|
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At baseline, mean PGA score was almost equal in Group A (3.0) and Group B (3.2), whereas the score was reduced in Group B (2.46, 1.8) compared to Group A (2.7, 2.1) in 2nd and 3rd (final) follow-up visits. At the final follow-up visit, both groups attained almost equal mean PGA score in Group A (1.8) and Group B (1.6) as shown in [Table 2].
The difference in mean PASI score is higher in the Group B (1.77 ± 0.85, 2.29 ± 1.079) during baseline to 1st follow-up and baseline to 2nd follow-up compared to Group A (0.42 ± 0.36, 1.3 ± 0.71) with a P < 0.00001. However, at the final follow-up, there was no significant change in the difference in mean PASI scores of both the groups, Group A (2.39 ± 1.31) and Group B (2.63 ± 1.14) with a P = 0.21 as shown in [Table 3].
|Table 3: Comparison of difference in Psoriasis Area Severity Index and Physician Global Assessment scores between two groups at each follow-up visit|
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The difference in mean PGA score was slightly greater in the Group B (0.55 ± 0.49, 1.425 ± 0.78, and 1.625 ± 0.74) during baseline to 1st follow-up, baseline to 2nd follow-up, and baseline to 3rd follow-up compared to Group A (0.4 ± 0.39, 1.05 ± 0.68, and 1.25 ± 0.61) with a P = 0.373, 0.53, and 0.64 as shown in [Table 3].
Other treatment outcomes such as rate of clearance was more in Group B (4; 10%) compared to Group A (2; 5.7%), responders and poor responders were almost equal in Group A (22; 62.8%, 23; 57.5%) and Group B (23; 57.5%, 9; 22.5%) and no deterioration and relapse rate was found in both groups as shown in [Table 4].
The mean cost-effectiveness ration of salicylic acid (94.45 ± 54.29) was less compared to clobetasol propionate (155.1 ± 74.4) at end of the treatment of limited chronic plaque psoriasis as shown in [Table 5].
|Table 5: Comparison of mean of cost-effectiveness ratio of salicylic acid 6% and clobetasol propionate 0.05% at the end of treatment phase|
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Stinging, itching, and burning were the common adverse effects observed on topical application of 5% salicylic acid. Discoloration of skin, flushing, dry skin, itching, and telangiectasias were the adverse effects observed on topical use of clobetasol propionate 0.06% as depicted in [Table 6].
|Table 6: Safety profile of topical salicylic acid 6% and clobetasol propionate 0.05%|
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| Discussion|| |
Plaque psoriasis was one of the most common forms of psoriasis which doesn't have a complete cure. Topical modalities were the mainstay for treatment of limited chronic plaque psoriasis. These include keratolytics, salicylic acid, corticosteroids, anthralin, photochemotherapy, and calcipotriol alone or in combination with topical steroids. Safe, effective, and economical long-term treatment and maintenance choices were required for managing chronic nature of psoriasis and to improve the quality of life. The antipsoriatic effect of salicylic acid and clobetasol propionate were individually reported in a number of studies. There was no published report on topical salicylic acid monotherapy versus clobetasol propionate monotherapy in limited chronic plaque psoriasis. The study was also measured costs associated with treatment; it will give best cost-effectiveness option in management-limited chronic plaque psoriasis.
Baseline demographic characteristics such as age, gender, and clinical characteristics such as redness, thickening, and scaling were closely matched between Group A (Salicylic acid 6%) and Group B (Clobetasol propionate 0.05%). The study findings show that mean PASI score and the difference in mean PASI score were significantly reduced in Group B compared to Group A in 1st and 2nd follow-up visits with a P < 0.00001, whereas at final follow-up, there was no significant difference in the mean PASI score in both groups with P = 0.21. These findings indicate, initial week's clobetasol propionate will show rapid improvement in symptom relief, but at the end of the treatment, both drugs were same in the achievement of clinical cure. Initial findings (PASI and PGA) of clobetasol propionate on 4th week and 8th week were similar with the findings of tazarotene 0.1% versus clobetasol propionate 0.05% study conducted by Angelo et al. However, at the end of treatment, our study results contrast with this study because in both groups reduction of PASI and PGA were equal but their study shows that clobetasol shows marked improvement at the end of treatment. The study found that there were no significant changes in mean PGA score and difference in mean PGA score of salicylic acid and clobetasol propionate in 1st, 2nd, and final follow-up visits.
At the end of treatment in both groups, there is a great number of complete clearance and responders, still, there were poor responders in whom PASI score reduction was <50%. These results were similar with findings of a study conducted by Guenther et al. Both drugs were well tolerated and no side effects were observed during the treatment phase of limited chronic plaque psoriasis which was similar with findings of coal-tar and betamethasone study conducted by Thawornchaisit and Harncharoen in Thailand.
The cost-effectiveness findings of the study show that salicylic acid was the best option compared to salicylic acid. This study was conducted in a small number of population and included only direct medical costs, so results may deviate if in a large sample with the inclusion of all costs such as direct, indirect, and intangible costs.
Most of the comparative studies were performed by considering clinical outcomes such as efficacy and safety, but this study will give insist for the inclusion of costs associated with drug therapy in the decision-making process. The major limitation of this study includes less number of samples and long-term safety of drugs was not explored in this trial.
| Conclusion|| |
In initial weeks, topical clobetasol propionate 0.05% has shown more effectiveness compared to salicylic acid 6% in limited chronic plaque psoriasis. Salicylic acid was cost-effectiveness option than clobetasol propionate at end of the treatment phase because both drugs were found to be equally safe and effective with no relapse or reoccurrence at the end of the treatment where only matter the cost of drugs.
All authors would like to thank the participants who are involved in the successful completion of this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| Annexure|| |
Annexure 1: Data Collection Form
A) Demographic Details:
1) Age:...... 2) Sex:...... 3) B.P.no.:..... 4) D.O.A.:...... 5) Height:...... 6) Weight:......
B) Drug prescribed: _________________________
c) Clinical Symptoms: (Tick if Yes)
Percentage of body involvement and body parts involved:
D) Efficacy Outcomes:
1) Primary Outcomes:
PASI score ((Psoriasis Area Severity Index) calculation - Scale is attached at end of the form.
2) Secondary Outcomes:
- PGA (Physician Global Assessment Scale):
E) Safety Assessment: During follow-ups:
F) Cost-Effective Analysis:
By Direct cost of therapy
1. FTUs = 0.5 gms of cream
Lumen of tube = 5Mm
- PGA (Physician Global Assessment Scale):
- Cost Effectiveness Ratio: Cost/Outcome
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]