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Bela Shah,1 Deval Mistry,2 Dharmender Jairam,1 Kajal Kansara,1 Rutvi Pandya,1 Presha Vasani,1 Dhiraj Dhoot,3 Namrata Mahadkar,3 Sumit Bhushan,3 Hanmant Barkate3 1Department of Dermatology, B J Medical College, Civil Hospital, Ahmedabad, Gujarat, India; 2Mistry Skin Clinic, Ahmedabad, Gujarat, India; 3Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Dhiraj Dhoot, Glenmark Pharmaceuticals Ltd., B D Sawant Marg, Near Bisleri Plant, Chakala, Andheri (E), Mumbai, 400099, India, Tel +919619811219, Email dddhoot@gmail.comIntroduction: Owing to pharmacokinetic challenges of itraconazole, super-bioavailable itraconazole (SB) was developed and recently approved in strengths of 50mg and 65mg. But comparative study was lacking between these two strengths in glabrous tinea (dermatophytosis) management. Hence, this study was planned to compare the efficacy of both these strengths in dermatophytosis.Methods: One hundred eligible patients were enrolled in this prospective, randomized, clinical study during May-2022 to September-2022 at tertiary hospital in Ahmedabad in adults. Efficacy and safety assessments were done at week-3 and 6 with follow up at week-10 for relapse. Primary objective was to assess the proportion of patients achieving complete cure at week-6 following treatment in both the groups. Secondary outcomes compared safety, clinical and mycological cure rates.Results: Of the 100 patients enrolled, 98 patients (50 in SB-50mg and 48 in SB-65mg group) included in the final analysis. At week 6, 20 patients (40%) and 30 patients (62.5%) achieved complete cure (p < 0.05) in SB-50mg and SB-65mg groups, respectively. In completely cured patients, relapse was reported in 3 (15%) and 5 (17%) patients of SB-50mg and SB-65mg groups, respectively (p = 1). A significant difference was noted in clearance of symptoms and lesions in SB-65mg group (p < 0.05). Moreover, similar results were also obtained in sub-group ana

Simon Fifer,1 Lili Toh,1 Hanmant Barkate,2 Vineet Aggarwal,2 Dhammraj Borade,2 Roger Hereward Gordonsmith,3 Wen Wu,3 Claire Morgan,4 Katherine Young4 1Community and Patient Preference Research (CaPPRe) Pty Ltd, Sydney, New South Wales, Australia; 2Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India; 3Global Medical Affairs, Glenmark Pharmaceuticals Europe Ltd, Watford, Hertfordshire, UK; 4Medical Affairs, Seqirus (Australia) Pty Ltd, Melbourne, Victoria, AustraliaCorrespondence: Simon Fifer, Community and Patient Preference Research (CaPPRe), Level 20, 25 Bligh Street, Sydney, New South Wales, 2000, Australia, Tel +61 403 862 091, Email simon.fifer@cappre.com.auPurpose: Combination intranasal corticosteroid and antihistamine sprays are a first-line treatment option for allergic rhinitis (AR), of which Azelastine Hydrochloride and Fluticasone Propionate nasal spray (AZE/FLU; Dymista®), and Olopatadine Hydrochloride and Mometasone Furoate Monohydrate nasal spray (OLO/MOM; Ryaltris®) are currently registered in Australia. As it is not known how patients value treatment attributes of current combination nasal sprays, this observational, real-world clinical study aimed to understand patients’ satisfaction with, and importance of, treatment attributes of OLO/MOM and AZE/FLU using an Anchored Best-Worst Scaling (ABWS) exercise.Participants and Methods: Four hundred and twenty-six adults in Australia with moderate to severe AR using either OLO/MOM or AZE/FLU completed an online survey incorporating an ABWS with 11 domains: 7 sensory (immediate taste of medication, aftertaste of medication, smell of medication, irritation to your nose, urge to sneeze, dripping out your nose/down your throat, dryness of your nose/throat) and 4 treatment-related (convenience, fast acting, duration of effect, and AR symptom control). The ABWS involved rescaling individual BWS scores using anchored ratings (0– 10) for most and least satisfied/important domains

Shenoy MM, De A, Shah B, et al. Drug Des Devel Ther. 2023;17:2899-2908. The authors have advised the affiliation indicators in the author list on page 2899 is incorrect. The correct author list and affiliations are as follows. Manjunath M Shenoy1, Abhishek De2, Bela Shah3, Anupam Das4, Abir Saraswat5, Koushik Lahiri2, Sheetal Yadav6, Aarti Sarda2, Disha Chakraborty7, Dharmender J3, Shruti Kamat3, Yashika Doshi3, Nelry Gonsalves3, Ankita Choudhary3, Dhiraj Dhoot8, Namrata Mahadkar8, Sumit Bhushan8, Rujuta Gadkari8, Hanmant Barkate8 1Department of Dermatology, Omega Hospital, Mangalore, Karnataka, India; 2Department of Dermatology, Wizderm Specialty Skin and Hair Clinic, Kolkata, West Bengal, India; 3Department of Dermatology, BJ Medical College and Civil Hospital, Ahmedabad, Gujarat, India; 4Department of Dermatology, Iris Multispecialty Hospital, Kolkata, West Bengal, India; 5Department of Dermatology, Indushree Skin Clinic, Lucknow, Uttar Pradesh, India; 6Department of Dermatology, ABVIMS and Dr. RML Hospital, New Delhi, India; 7Department of Dermatology, Calcutta National Medical College, Kolkata, West Bengal, India; 8Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India The authors apologize for this error.

Manjunath M Shenoy,1 Abhishek De,2 Bela Shah,3 Anupam Das,4 Abir Saraswat,5 Koushik Lahiri,2 Sheetal Yadav,6 Aarti Sarda,2 Disha Chakraborty,7 Dharmender J,2 Shruti Kamat,2 Yashika Doshi,2 Nelry Gonsalves,2 Ankita Choudhary,2 Dhiraj Dhoot,8 Namrata Mahadkar,8 Sumit Bhushan,8 Rujuta Gadkari,8 Hanmant Barkate8 1Department of Dermatology, Omega Hospital, Mangalore, Karnataka, India; 2Department of Dermatology, Wizderm Specialty Skin and Hair Clinic, Kolkata, West Bengal, India; 3Department of Dermatology, BJ Medical College and Civil Hospital, Ahmedabad, Gujarat, India; 4Department of Dermatology, Iris Multispecialty Hospital, Kolkata, West Bengal, India; 5Department of Dermatology, Indushree Skin Clinic, Lucknow, Uttar Pradesh, India; 6Department of Dermatology, ABVIMS and Dr. RML Hospital, New Delhi, India; 7Department of Dermatology, Calcutta National Medical College, Kolkata, West Bengal, India; 8Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Dhiraj Dhoot, Glenmark Pharmaceuticals Ltd, B D Sawant Marg, Chakala, Andheri (E), Mumbai, India, 400099, Tel +91 9619811219, Email dddhoot@gmail.comIntroduction: Itraconazole follows non-linear pharmacokinetics and hence is recommended once daily, but in real-world practice, is commonly prescribed as twice daily. Hence, this study aimed to evaluate the efficacy and safety of super-bioavailable-itraconazole-130 mg (SB-130) and conventional-itraconazole-200 mg (CITZ-200) once daily compared with conventional-itraconazole-100 mg (CITZ-100) twice daily in glabrous tinea.Methods: A total of 261 eligible patients were enrolled in this prospective, randomized, clinical study from December-2021 to August-2022 at seven centers in India. Efficacy and safety assessments were done at week-3 and 6, with follow-up at week-10 for relapse. The primary objective was to assess the proportion of patients who achieved complete cure at week-6 following treatment in all itraconazole gr

Vishalakshi Viswanath,1 Pradnya Joshi,1 Mayuri Dhakne,1 Dhiraj Dhoot,2 Namrata Mahadkar,2 Hanmant Barkate2 1Department of Dermatology, Rajiv Gandhi Medical College, Thane, Maharashtra, India; 2Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Namrata Mahadkar, Email namratamahadkar@gmail.comIntroduction: Lichen planus is a chronic disease with often disappointing and less than optimal treatment options. Apremilast modulates inflammatory signalling pathways which play a central role in the pathogenesis of lichen planus, thus making it useful in the management of such patients.Materials and Methods: The present study was an investigator-initiated, single-centre, non-randomized, open-label, pilot study of the efficacy and safety of Apremilast in the treatment of lichen planus. All the patients were prescribed Apremilast 30mg, twice daily, for 12 weeks. Patients were evaluated for improvement in their lesions, based on the physician’s global assessment (PGA), subject global assessment (SGA), and target area lesion symptom score (TALSS).Results: A total of 34 patients were included in the study; 26 patients completed the study duration and were considered for the final analysis. After 12 weeks, 34.61% (n = 9/26) patients showed 2 or more grade improvement in their disease as per PGA. About 42.30% (n = 11/26) patients achieved more than 50% improvement in their lesions based on the subject global assessment of their disease. There was a significant improvement in TALSS during the study period (p < 0.0001). Only 23.07% (n = 6/26) patients developed one or more adverse events because of Apremilast with headache being the commonest side effect.Conclusion: The results obtained in our study justify that Apremilast is efficacious and safe in the management of patients with lichen planus. Based on these results, Apremilast can be considered as a promising alternative treatment option in patients with lichen planus.Keywords: Apre

Shashank Joshi,1 Agam Vora,2 K Venugopal,3 Pramod Dadhich,4 Anil Daxini,5 Sagar Bhagat,6 Saiprasad Patil,6 Hanmant Barkate6 1Department of Endocrinology, Joshi Clinic and Lilavati Hospital and Research Centre, Mumbai, India; 2Department of Pulmonology, Vora Clinic, Mumbai, India; 3Department of Pulmonology, Sooriya Hospital, Chennai, India; 4Department of Pulmonology, Dadhich Clinic, Ajmer, India; 5Department of Medicine, Fortis Hospital, Mumbai, India; 6Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, IndiaCorrespondence: Sagar Bhagat, Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India, Tel +91 9930553638, Email sagar.bhagat@glenmarkpharma.comBackground: Favipiravir, an RNA-dependent RNA polymerase inhibitor (RdRp), is a broad-spectrum oral antiviral agent approved in India under emergency use authorization, for the treatment of mild-to-moderate coronavirus disease (COVID-19). The present study was planned to evaluate the effectiveness and safety of favipiravir in real-world clinical practice.Materials and Methods: This was a multicentric, retrospective, single-arm study conducted across four centres in India, after obtaining permission from the independent ethics committee. Medical records were analysed to evaluate effectiveness and safety of patients who were prescribed favipiravir.Results: The medical records of a total of 360 patients met the inclusion criteria, with 358 of them available for the final analysis. Males made up 58.46% of the study population. The average age of enrolled patients was 51.80 ± 16.45 years. The most common symptoms were fever, cough, and myalgia-fatigue. The median time to clinical cure and fever relief was five and four days, respectively. The average length of stay in the hospital was six days. In total, 8% of the patients experienced adverse events. Hepatic enzyme elevation, diarrhoea, decreased appetite, headache, fatigue, and giddiness were the common symptoms.Conclusion: In our real-world study, f

Vishalakshi Viswanath,1 Pradnya Joshi,1 Prakash Lawate,1 Dakshata Tare,1 Dhiraj Dhoot,2 Namrata Mahadkar,2 Hanmant Barkate2 1Department of Dermatology, Rajiv Gandhi Medical College, Thane, Mumbai, India; 2Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Dhiraj Dhoot, Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, B D Sawant Marg, Andheri (E), Mumbai, Maharashtra, 400099, India, Tel +91 9619811219, Email dddhoot@gmail.comPurpose: To minimize adverse effects (AEs), apremilast is recommended to titrate at the initiation of therapy. But still, many patients experience AEs, resulting in discontinuation of therapy. As a result, many dermatologists have adapted to further titrate apremilast in different ways. The present study was planned to evaluate the safety and effectiveness of apremilast in different dose titration methods as initiation therapy in the treatment of plaque psoriasis.Patients and Methods: In this open-label, randomized, prospective, comparative, three-arm, single center study, 128 plaque psoriasis patients were included. Patients were randomized into three groups. Group I received standard titration for the first 6 days; Group II received all tablets in a starter pack as once a day (OD) total for 13 days; and Group III received two starter packs as 8 tablets each of apremilast 10 mg and 20 mg as OD and 10 tablets of 30 mg as OD, in total for 26 days. All groups received apremilast 30 mg as twice a day after initial titration. The total duration of apremilast therapy in all groups was 16 weeks.Results: In safety assessment, AEs were reported in 50%, 41.3% and 25% in Groups I, II and III, respectively (p < 0.05) with nausea being the most common AE. In Group I, 10.53% of patients discontinued apremilast whereas 6.52% and 2.27% discontinued in Groups II and III respectively. Maximum number of AEs were seen in Group I in first week only (74.19%) compared with other groups. A

Pavan Kumar Reddy,1 Saiprasad Patil,2 Akash Khobragade,3 Akash Balki,4 Aneesh Raj,5 Mrunalini Kalikar,6 Raghavendra Reddy,7 Ravindra Shinde,8 Jayanthi CR,9 Abhinandan Mutha,10 Nagaraju Boyilla,11 Girish C Rajadhyaksha,12 Niteen Karnik,13 Sagar Bhagat,2 Amol Pendse,14 Priyanka Dhage,15 Wen Wu,16 Shabbir Rangwala,14 Hanmant Barkate2 1Critical Care Medicine, Care Hospital, Hyderabad, Telangana, India; 2Global Medical Affairs, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India; 3St. George’s Hospital, Mumbai, Maharashtra, India; 4Shree Hospital & Critical Care Center, Nagpur, Maharashtra, India; 5NIMS Medicity, Trivandrum, Kerala, India; 6Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India; 7Renova Neelima Hospitals, Hyderabad, Telangana, India; 8Respiratory Medicine, Dr Vasantrao Pawar Medical College, Nashik, Maharashtra, India; 9Bangalore Medical College, Bengaluru, Karnataka, India; 10Siddhi Hospital, Nasik, Maharashtra, India; 11Aster Prime Hospital, Hyderabad, Telangana, India; 12Department of Medicine, BYL Medical college & Nair Hospital, Mumbai, Maharashtra, India; 13Department of Medicine, LT Medical College & Sion Hospital, Mumbai, Maharashtra, India; 14Clinical Research Operations, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India; 15Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India; 16Glenmark Pharmaceuticals Ltd., Waterford, UKCorrespondence: Sagar Bhagat, Tel +919930553638, Email Sagar.Bhagat@glenmarkpharma.comPurpose: To evaluate the safety and efficacy of favipiravir, which is prescribed for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) in India.Patients and Methods: This was a prospective, open-label, multicenter, single-arm postmarketing study conducted in India. Patients with mild-to-moderate COVID-19 received favipiravir (3600 mg [1800 mg orally twice daily] on the first day, followed by 800 mg orally twice daily, up to a maximum of 14 days) as a

Bela Shah,1 Dhiraj Dhoot,2 Ankita Choudhary,1 Neha Jangid,1 Deval Mistry,1 Shikha Shah,1 Shruti Kamat,1 Hanmant Barkate3 1Department of Dermatology, Venereology and Leprosy, B.J.Medical College, Civil Hospital, Ahmedabad, India; 2DGM, Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India; 3Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, IndiaCorrespondence: Dhiraj Dhoot, DGM, Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, 400099, India, Tel +91 9619811219, Email dddhoot@gmail.comIntroduction: Though second-generation antihistamines (SGAH) are first-line drugs in chronic spontaneous urticaria (CSU), 50% of patients do not respond to them. In such patients, guidelines recommend either up-dosing of SGAH or combination of different antihistamines. However, the studies comparing these treatment regimens are limited.Methods: In this comparative, three-arm study, CSU patients were randomized to receive standard dose of either bilastine, fexofenadine, or levocetirizine for 2 weeks. After 2 weeks of treatment, non-responders received double dose of either bilastine or fexofenadine, while hydroxyzine 25 mg once daily was added in the levocetirizine group. Patients were primarily evaluated for improvement in CSU, quality of life, and somnolence.Results: A total of 110 patients with CSU were recruited. At the end of 4 weeks, 33/39, 26/35, and 22/36 patients in the bilastine, fexofenadine, and levocetirizine groups showed improvement in urticaria symptoms. At week 2, there was no statistical difference in urticaria activity score (UAS7) improvement between any of the groups; however, at week 4, there was a statistical difference between the bilastine and levocetirizine groups (p< 0.05). Somnolence was significantly lower in the bilastine group (p< 0.05). Bilastine was statistically significant (p< 0.05) in the improvement of quality of life as compared to both groups. No ma

Manjunath Shenoy,1,2 Dhiraj Dhoot,3 Harshal Mahajan,3 Hanmant Barkate3 1Department of Dermatology, Yenepoya Medical College, Deralakatte, Mangalore, India; 2Omega Hospital, Mangalore, Karnataka, India; 3Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Dhiraj DhootGlobal Medical Affairs, Glenmark Pharmaceuticals Ltd, B D Sawant Marg, Andheri (E), Mumbai, Maharashtra, 400099, IndiaTel +91 9619811219Email dhiraj.dhoot@glenmarkpharma.comPurpose: A new oral formulation of itraconazole, called super bioavailable itraconazole (SBITZ), has been launched in India, exhibiting greater bioavailability than conventional itraconazole (CITZ). No clinical studies on its effectiveness and safety in dermatophytosis in comparison with CITZ have been conducted in India. Hence, the aim of this clinical study was to compare the effectiveness and safety of SBITZ capsules and CITZ capsules in dermatophytosis.Patients and Methods: This was an open-label, randomized, double-arm clinical study in which 70 patients (≥ 18 years of age) of either gender and diagnosed with tinea cruris, tinea corporis, and/or tinea faciei were included. The study was divided into two parts, the first part comprising a treatment period of 4 weeks and the second part an observation period for recurrence, comprised of another 4 weeks, thus making an entire study duration of 8 weeks.Results: Of the 70 patients enrolled in this study, 59 (33 patients in the CITZ group and 26 patients in the SBITZ group) were included in the final analysis. In both groups, most patients were diagnosed with tinea cruris et corporis, with five or more lesions. At week 4, 11 patients (33.33%) and 17 patients (65.38%) had achieved complete cure (p< 0.05), whereas 22 patients (66.67%) and 22 patients (84.61%) had achieved mycological cure (p=0.14), in the CITZ and SBITZ groups, respectively. During the observation period, recurrence was seen in 1/11 and 4/17 completely cured patients in th