ABSTRACT
Background: Tinea corporis is a common dermatophytic infection of the body involving keratin layer of skin. This lesion presents as an annular plaque with an advancing border along with central clearing. Clotrimazole is topical, conventional imidazole antifungal drug and has given good efficacy in tinea corporis. Sertaconazole is new topical imidazole antifungal claimed to be superior to old topical imidazoles in tinea corporis. The aim of this study was to compare efficacy, safety and cost effectiveness of topical antifungals, clotrimazole 1% cream and sertaconazole 2% cream in patients suffering from mild to moderate tinea corporis attending out-patient department of tertiary care hospital in Vidarbha region of Maharashtra. Methods: This was a prospective, comparative, randomized trial with 2 parallel treatment arms of 4 weeks duration. Patients were diagnosed on the basis of clinical evaluation and microscopic findings of KOH mount. Hundred patients were randomly assigned into two groups of clotrimazole 1% cream, and sertaconazole 2% cream with 50 patients in each group. Evaluation was carried out at baseline, 1st week, 2nd week and 4th week for efficacy parameters viz. itching, erythema and scaling, physician’s global assessment (PGA), safety and cost effectiveness. Results: Topical sertaconazole 2% cream was highly efficacious and superior to clotrimazole 1% cream in improvement of clinical parameters, PGA and mycological cure at the end of the treatment phase. At end of the follow-up phase both the trial drugs were effective with no recurrence or relapse of tinea corporis. However, clotrimazole 1% cream was safe and cheaper. Conclusions: Topical clotrimazole 1% cream and sertaconazole 2% were effective and well tolerated in patients of tinea corporis. Effectiveness of sertaconazole was early and superior with tolerable side-effects. However, clotrimazole was costeffective.
ABSTRACT
Background: Package inserts are the authentic source of information for the new molecules in the market. Incomplete and incorrect product information may promote irrational prescribing and may have serious consequences. Hence, our aim was to analyse and compare the information supplied in the package insert according to the section 6.2 and section 6.3 of schedule D of Drugs and Cosmetic Act, 1940 in public (government) and private (non-government) sector. Methods: Package inserts of allopathic drugs which were supplied by government from drug store of tertiary care centre and hospital and from pharmacies on request were collected. A total of 270 package inserts in English were collected that is 38 from government hospital and 232 from the pharmacies nearby the hospital. The package inserts were analysed for the presentation of completeness of the information as per section 6.2 and 6.3. Results: The presentation of information on analysing 233 package inserts (28 government and 205 non government) was not uniform and it was difficult to locate and retrieve information easily due to lack of common layout and heading. Moreover, the package inserts were of variable shape and size with different font size which made it inconvenient for analysing as well as for reference. Posology and method of administration was incomplete in 3% package insert in non- government cases whereas in government supply it was 7%. Use of drug in pregnancy and lactation was deficient in 11% and 14% packages inserts of non-government sources and government sources respectively. Instructions for use were lacking in 25% and 29% package inserts of government and non-government sources respectively. Conclusions: The need of the hour is to further refine contents of the circulated package inserts to make them complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society.