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Background: Psoriasis is an inflammatory systemic disease with a chronic relapsing course. Methotrexate, a dihydrofolate reductase inhibitor, and Apremilast, an oral phosphodiesterase type 4 inhibitor, are currently the mainstay drugs in the treatment of psoriasis. Aims and Objectives: To compare the efficacy of Methotrexate with a combination of Methotrexate and Apremilast in treating chronic plaque psoriasis. Materials and Methods: The present study was a prospective comparative study conducted among 40 patients, aged above 18 years, with clinically diagnosed psoriasis attending Dermatology OPD of a tertiary care hospital in North India. The study utilised a pre-structured proforma to record a detailed demographic profile and clinical examination related to chronic plaque psoriasis. The patients were divided into two groups of 20 each. Group A was treated with oral Methotrexate, while Group B was treated with oral Apremilast and Methotrexate, and they were evaluated every 4 weeks for 12 weeks. Necessary investigations were done wherever indicated. Results: The male-to-female ratio was 1.35, and the majority (55.0%) of patients belonged to the age group of 31-50 years. 27.5% of patients had comorbidities like diabetes, hypertension, etc., The mean PASI score of group A at the first, second and third follow-ups was higher than that of group B. The reduction in mean PASI score was statistically significant in group B at successive follow-ups, with a percentage improvement of 89.4% at the end of 12 weeks. Conclusions: When comparing monotherapy with methotrexate and multidrug therapy with Methotrexate and Apremilast, multidrug therapy had better efficacy. [ABSTRACT FROM AUTHOR]

Determining the appropriate sample size for a study, whatever be its type, is a fundamental aspect of biomedical research. An adequate sample ensures that the study will yield reliable information, regardless of whether the data ultimately suggests a clinically important difference between the interventions or elements being studied. The probability of Type 1 and Type 2 errors, the expected variance in the sample and the effect size are the essential determinants of sample size in interventional studies. Any method for deriving a conclusion from experimental data carries with it some risk of drawing a false conclusion. Two types of false conclusion may occur, called Type 1 and Type 2 errors, whose probabilities are denoted by the symbols σ and β. A Type 1 error occurs when one concludes that a difference exists between the groups being compared when, in reality, it does not. This is akin to a false positive result. A Type 2 error occurs when one concludes that difference does not exist when, in reality, a difference does exist, and it is equal to or larger than the effect size defined by the alternative to the null hypothesis. This may be viewed as a false negative result. When considering the risk of Type 2 error, it is more intuitive to think in terms of power of the study or (1 - β). Power denotes the probability of detecting a difference when a difference does exist between the groups being compared. Smaller α or larger power will increase sample size. Conventional acceptable values for power and α are 80% or above and 5% or below, respectively, when calculating sample size. Increasing variance in the sample tends to increase the sample size required to achieve a given power level. The effect size is the smallest clinically important difference that is sought to be detected and, rather than statistical convention, is a matter of past experience and clinical judgment. Larger samples are required if smaller differences are to be detected. Although the principles are long known, historically, sample size determination has been difficult, because of relatively complex mathematical considerations and numerous different formulas. However, of late, there has been remarkable improvement in the availability, capability, and user-friendliness of power and sample size determination software. Many can execute routines for determination of sample size and power for a wide variety of research designs and statistical tests. With the drudgery of mathematical calculation gone, researchers must now concentrate on determining appropriate sample size and achieving these targets, so that study conclusions can be accepted as meaningful. [ABSTRACT FROM AUTHOR]

Objective: To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria. Materials and Methods: A 6-week, single-centered, randomized, double blind, parallel group comparative clinical study was conducted on patients with chronic spontaneous urticaria. Following inclusion and exclusion criteria, 60 patients were recruited and were randomized to two treatment groups and received the respective drugs for 6 weeks. At follow-up, parameters assessed were mean total symptom score (MTSS) calculated by adding the mean number of wheals (MNW) and the mean pruritus score (MPS), number of wheals, size of wheal, scale for interference of wheals with sleep (SIWS). Results: Both the drugs significantly reduced the MTSS, number of wheals, size of wheal, scale for interference of wheals with sleep, but olopatadine was found to be superior. In olopatadine group, there was significantly higher reduction in MTSS (p = 0.01), Number of wheals (P < 0.05), Size of wheals (p < 0.05), Scale for intensity of erythema (p < 0.05) and change in eosinopils count (p = 0.015) than that of rupatadine. Incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group. Cost effectiveness ratio was less in olopatadine group as compared to rupatadine group throughout the treatment. Conclusions: Olopatadine is a better choice in chronic spontaneous urticaria in comparison to rupatadine due to its better efficacy, safety and cost effectiveness profile. [ABSTRACT FROM AUTHOR]

Background: The diagnosis of pityriasis rosea (PR) is generally clinical. Previous studies usually recruited relatively small numbers of patients and control subjects, leading to low power of study results. Systematic reviews and meta-analyses cannot be readily performed, as the inclusion and exclusion criteria of these studies were not uniform. We have previously validated a set of diagnostic criteria (DC) in Chinese patients with PR. Aim: Our aim is to evaluate the validity and applicability of the DC of PR in Indian patients with PR. Study Design: Prospective unblinded pair-matched case-control study. Materials and Methods: The setting is a dermatology clinic in India served by one board-certified dermatologist. We recruited all 88 patients seen by us during five years diagnosed to have PR to join our study. For each study subject, we recruited the next patient who consulted us with differential diagnoses of PR as control subjects. We applied the DC of PR on all study and control subjects. Result: The sensitivity, specificity, positive predictive value, and negative predictive value of the DC were all 100%. Two-tailed Fisher’s exact probability test result was 0.036. Φ was 1.00. Conclusion: The set of DC can be validly applied to Indian patients with PR. [ABSTRACT FROM AUTHOR]

Introduction: One of the most important complications after burning is hypo/depigmentation. This study was designed to compare two methods of cell spray and intradermal injection of epidermal cell suspension for treatment of burn induced hypopigmentation. Material and Methods: In this study, 28 patients with post burn hypo/depigmentation were selected and divided in 2 groups. A small skin biopsy was taken from normal skin of patients in operation room and epidermal cell suspension was prepared using NaBr 4N and trypsin. In the first group, the epidermal cell suspension was sprayed on the wound surface and then the area was dressed with amniotic membrane and gauze. In the second group, the cell suspension was injected in intradermal manner in the hypopigmented area. The patients were followed up and to evaluate the effect of the cells, photos were taken from the area before operation and also at follow?up. Clinical evaluation was done by the surgeon and a clinical score between "0" to "4" was used to demonstrate the clinical status from poor to excellent pigmentation. Skin biopsies were taken from depigmented area before and after interventions. Melanocytes were stained using anti S100 antibody and were counted in ×400 magnification fields. Results: Eighteen patients were in cell spray and 10 were in cell injection groups. Mean change of pigmentation in two group showed that there was no statistical significant differences in pigmentation between two groups, (P value = 0.52) although a limited improvement in pigmentation status was observed in both groups. Regarding melanocyte numbers per field, there was not a significant difference between two groups and also before and after interventions, but melanocyte number increased after treatment in both groups. Conclusion: We did not find noticeable differences between cell spray and intradermal injection methods. Although both methods showed a limited effect on pigmentation of depigmented skin, the clinical results were not satisfactorily for both patients and clinicians. [ABSTRACT FROM AUTHOR]

Background: Topical steroids remain the mainstay of treatment in eczema, an inflammatory skin reaction characterized by pruritus, redness, scaling, and clustered oozing papulovesicles. Halometasone is a new potent corticosteroid approved in the Indian market for topical application in the treatment of dermatitis. Aims: To evaluate the efficacy and safety of halometasone in the treatment of acute or chronic noninfected eczematous dermatosis in Indian population. Materials and Methods: A prospective, open, multicentric, phase 3, noncomparative clinical trial conducted at outpatient departments of seven centres. Two hundred endogenous eczema patients meeting study criteria were enrolled. Halometasone 0.05% cream was applied twice daily for 30 days in chronic and 20 days in acute eczema patients. Calculation of eczema area and severity index, and assessment of investigator's global assessment of severity of eczema and severity of pruritus score were done at each visit and compared with baseline. All adverse events (AE) were captured and documented. Laboratory investigations including haematological tests, urinalysis, renal and liver function tests were performed at baseline and at end of treatment. Results: Of the 200 patients enrolled, 180 were chronic and 20 were acute eczema patients. It was found that there was a significant (P<0.001) improvement in all efficacy parameters compared with baseline. The treatment was shown to be successful in 91% patients. AE were reported in 30 patients and there was no serious AE reported. There was no clinically significant difference in laboratory investigations with treatment. Conclusions: Halometasone was shown to be safe and very effective in Indian patients with acute and chronic eczema and the drug was well tolerated. [ABSTRACT FROM AUTHOR]

Background: Vascular endothelial dysfunction is a central event in pathogenesis of a variety of human diseases. Systemic sclerosis is one of such diseases.The oxidative stress and depletion of antioxidants in the serum is believed to be one of the factors in causing this dysfunction. Aims: The aim of this case control study was to compare the levels of antioxidants in the serum of patients with systemic sclerosis and the normal age and sex matched controls. Materials and Methods: Our study consisted of 16 successively admitted patients with systemic sclerosis and 16 healthy, age and sex matched controls. The age group of patient's ranged between 25 and 55 years. The duration of the disease in patients ranged from 1 to 8 years. The serum of patients and controls were assayed for the levels of antioxidants (GSH, NO, MDA, SOD and GPX) by spectrophotometry. The statistical method of analysis used was the one sample t-test. Results: The median levels of antioxidants in the control patients were: SOD-4.14 units/ml; GSH-4.76 units/ml; NO-5.58 nmol/l; MDA-0.53 nmol/l and GPX-49 µmol/l. The levels of NO, GSH and SOD were decreased in these patients with a significant P value (<0.001) whereas the levels of GPX and MDA were normal to increased with a significant P value. Conclusion: The depletion of antioxidants and oxidative stress in serum might be responsible for the vascular dysfunction and other hallmark manifestations of systemic sclerosis. Therefore micronutrient antioxidant supplements may be of therapeutic value. [ABSTRACT FROM AUTHOR]