<p>In recent times, India has witnessed a steep surge in prescription of itraconazole in the management of dermatophytosis.<sup>1</sup> But due to its pharmacokinetics, it has shown multiple variations in the results. To overcome these challenges, a newer itraconazole formulation i.e. super-bioavailable itraconazole (SBITZ) has been launched recently in India. Currently, there are 4 different strengths of SBITZ which are approved by DCGI.<sup>2,3</sup> But there is no any clinical data regarding comparison of different strength of SBITZ. This retrospective analysis aimed to compare two different strengths of SBITZ; 50 mg and 65 mg in the management of dermatophytosis.</p>
Background Due to changing face of dermatophytosis in India, many dermatologists practice different dosing patterns of itraconazole (ITZ). Recently, a new form of ITZ, super-bioavailable ITZ (SBITZ), has been commercialized to overcome the pharmacokinetic challenges of conventional ITZ (CITZ). Serum and sebum concentration of ITZ plays an important role in the management of dermatophytosis. Hence, the current study compares the rate and extent of serum and sebum concentration of SBITZ and CITZ at different dosing to determine their efficacy and safety in patients with dermatophytosis. Methods This was an open-label, randomized, four-arm study including 40 adult patients diagnosed with glabrous tinea who were randomized equally into four groups to receive either CITZ-100-BD or CITZ-200-OD (2×100 mg capsules) or SBITZ-130-OD or SBITZ-100-OD (2×SBITZ-50 mg capsules) for 4 weeks. Serum and sebum samples were analysed at different time intervals along with clinical efficacy and safety. Results For serum concentration, on day 28, the arithmetic mean and standard deviation (SD) for CITZ-100-BD, CITZ-200-OD, SB-130-OD and SB100-OD were 1262±233.5 ng/mL, 1704±261.6 ng/mL, 1770±268.9 ng/mL and 1520±231.7 ng/mL, respectively, which was statistically significant for OD dosing of ITZ/SBITZ over CITZ-100-BD. Similarly, for sebum concentration, the arithmetic mean and SD for CITZ-100-BD, CITZ-200-OD, SB-130-OD and SB-100-OD were 1042±163.45 ng/mg, 1423±192.46 ng/mg, 1534±227.55 ng/mg and 1107±182.35 ng/mg, respectively, which was statistically significant for SB-130-OD and CITZ-200-OD over CITZ-100-BD and SBITZ-100-OD dosing. No significant difference was noted between SBITZ-130 and CITZ-200 ( p =0.25). Only two patients achieved complete cure in the SBITZ-130 group, whereas no patients achieved the same in other groups ( p =0.47). All the dosages were very well tolerated with only 12 adverse events reported by ten patients in all groups. Conclusion All formulations achieved desired serum and sebum concentrations required for efficacy in dermatophytosis, but SB 130 mg OD and CITZ 200 mg OD were statistically significant than other ITZ doses in achieving sebum concentration. Additionally, SBITZ 130 mg OD was bioequivalent to CITZ 200 mg OD and achieved similar results to those of CITZ 200 mg OD but at 35% lower drug concentrations.
<p>Super-bioavailable itraconazole (SBITZ) is a new form of itraconazole which overcomes the pharmacokinetic issues of conventional itraconazole (CITZ). Currently two strengths are approved globally for SBITZ; 50 mg and 65 mg which exhibit greater bioavailability than CITZ and widely prescribed in systemic mycosis and dermatophytosis. Though both the strengths have proven to be bioequivalent with CITZ 100 mg but difference was reported in achieving therapeutic concentration of ITZ in patients. Secondly, skin kinetics study in terms of sebum concentration is lacking for both the strengths.</p>
<p><strong>Introduction: </strong>Moisturizers account for the largest and important skin care product categories and are the backbone in the management of dry skin conditions associated with atopic dermatitis (AD), psoriasis and ichthyosis. </p><p><strong>Methods: </strong>A multicentre, retrospective data analysis was done at 145 dermatology clinics across India in patients who were prescribed MaxRich®. Patients with history of xerosis with an identifiable causes like atopic dermatitis, psoriasis and ichthyosis were included in study. Effectiveness data in terms of improvement in Dry Skin Area and Severity Index (DASI) Score compared to baseline and physician global assessment at the end of treatment for improvement in xerosis were captured.</p><p><strong>Results: </strong>There was significant reduction in mean DASI score as compared to baseline at week 2 & 4 (p<0.01). As compared to baseline, a significant decrease in DASI score was observed by 47.7% and 82.4% at the end of week 2 and 4 respectively. As per physician global assessment, 458 patients (83.4%) noticed very good improvement in xerosis at the end of 4 weeks whereas 82 patients (14.9%) recorded moderate improvement. Similar results were also obtained for patient global assessment where 478 patients (87%) recorded very good improvement; 67 patients (12.2%) and 6 patients (1.1%) recorded moderate and mild improvement respectively. There were no adverse events reported with MaxRich®.</p><p><strong>Conclusion: </strong>MaxRich®, an intense moisturizer was effective in improvement of DASI score associated with atopic dermatitis, psoriasis and ichthyosis and can be considered as an adjunct therapy in the management of these skin disorders for better results.</p>
Sir, Atopic dermatitis (AD) is a skin disease with complex genetic background which is chronic and pruritic inflammatory in nature with lifetime prevalence of 20%. [1] Topical corticosteroids (TCS) remain mainstay in treatment in spite of availability of multiple treatment options. [2] TCS are a class of hydrocortisone derivatives with variable potency and having anti-inflammatory as well as anti-pruritic properties but with the side effects profile. [3] In some clinical settings, while least potent corticosteroids may be sufficient, but same medication may not be effective in long-term management. [4] In such situation, mid-to high-potent TCS are favored. Mometasone furoate 0.1% (MF) and fluticasone propionate 0.005% (FP) creams are the two most commonly prescribed TCS, either as once daily (OD) or twice daily (BD) in the management of AD, respectively. Due to dearth of comparative data between these two drugs, this retrospective study was aimed to compare clinical assessment in the treatment of AD. A retrospective data analysis was done at 186 dermatology clinics across India after obtaining ethics committee approval (Suraksha Ethics Committee Regd No. ECR/644/Inst/ MH/2014/RR-20 Dated August 18, 2021). The data charts were identified by creating a list of patients (age ≥2 years) prescribed either MF or FP cream at all clinics, using the medical record database. Patients with incomplete data were excluded from the study. Effectiveness was assessed by Atopic Dermatitis Severity Index (ADSI) [5] and Investigator Global Assessment (IGA). ADSI (range, 0-15) consists of the sum of the scores for all symptoms such as erythema, pruritus, excoriation, exudation, and lichenification, with scoring on a 4-point scale (range, 0-3). IGA is graded on a 4-point scale (0 being clearance of the signs and symptoms and 4 beingThis is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, transform, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
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