An Open, Comparative, Randomized, Parallel, Post Marketing, Multicentric Trial to Compare the Safety and Efficacy of Formula A (Ofloxacin + Ornidazole + Terbinafine Hydrochloride + Clobetasol Propionate) versus Formula B (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate), Formula C (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) and Formula D (Clotrimazole + Beclometasone Dipropionate + Neomycin Sulphate) in the Treatment of Patients with Vaginitis.

Vaginitis is among the most common conditions for which women seek medical care, with vaginal discharge accounting for approximately 10 million office visits each year. Since there are no published studies till date that evaluated the Clinical Effectiveness and Safety of Topical Cream of Formula A [Ofloxacin (0.75 % w/w) + Ornidazole (2% w/w) + Terbinafine Hydrochloride (1% w/w) + Clobetasol Propionate (0.05% w/w)] compared to Formula B [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], Formula C [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], and Formula D [Clotrimazole (1%w/w) + Beclometasone Dipropionate (0.025%w/w) + Neomycin Sulphate (0.5% w/w)], in mild to moderate vaginitis, hence we undertook this randomized controlled Post Marketing Multicentric trial. Materials and methods: Female subjects diagnosed with mild to moderate symptoms of Vaginitis were eligible and those fulfilling the subject selection criteria were randomized to receive either Formula A, Formula B, Formula C or Formula D for 14 days. The Primary efficacy measures were assessment of symptoms of Vaginitis i.e. vaginal pruritis, vaginal irritation, vaginal soreness or pain, dyspareunia, vaginal erosion and vaginal inflammation and Secondary efficacy measures were assessment of Physical characteristics of vaginal discharge, assessment of pH of vaginal discharge and Microbiological evaluation. Assessment of Safety was done by recording the occurrence of adverse drug reactions. Results: The clinical success rates were comparable and even far better in case of Formula A group (in vaginal pain, Dyspareunia and vaginal erosion it was 100 %, in case of vaginal inflammation it was 92.655 % while in case of vaginal irritation, it was 94.767 % and vaginal pruritus, it was 87.096 %). Adverse events were mild and self limiting while it was totally absent in case of Formula A group. Conclusion: Topical Cream of Formula A is safe and effective for the treatment of mild to moderate vaginitis.

Comparison of the Minimum Fungicidal Concentration of Clotrimazole, Ketoconazole, Miconazole and Terbinafine Against Clinical Isolates of Dermatophytes.

Superficial fungal infections affect millions of people worldwide. Earlier most dermatophyte strains had relatively restricted geographical distribution. But currently, dermatophytosis has become one of the most common human infectious diseases worldwide. Fungal infections are common in hot and humid climate of tropical countries like India. Topical and systemic therapies are commonly used to treat dermatophyte infections.Clotrimazole is one of the most commonly used topical antifungal drugs. This study compared the minimum fungicidal concentration (MFC) of Clotrimazole with Miconazole, Ketoconazole and Terbinafine in skin dermatophytes. The study demonstrated that Clotrimazole had lower MFCs as compared to Ketoconazole and Miconazole against Trichophyton rubrum, Trichophyton mentagrophytes and Microsporum canis. Clotrimazole had comparable MFCs versus Terbinafine against Trichophyton rubrum but it had lower MFCs against Trichophyton mentagrophytes and Microsporum canis. Thus, Clotrimazole is an effective antifungal agent for dermatophytosis even today.The efficacy of Clotrimazole even against strains with intermediate resistance or resistance to the older azole anti fungal drugs reiterate the current decisions of empirical treatment with topical Clotrimazole for the management of superficial dermatophyte infections.

[Safety and efficacy of terbinafine in a pediatric Iranian cohort of patients with Tinea capitis]

Tinea capitis is a common infection of the scalp and hair shaft caused by dermatophyte fungi that mainly affects prepubescent children. Systemic therapy is required for treatment and to prevent spread. The aim of present study was to assess the effect of terbinafme for tinea capitis treatment in children. 30 Iranian pediatric patients with a clinical diagnosis of tinea capitis, were enrolled in the study. The Study was conducted in a general and referral teaching hospital [Imam Medical Centre - Tehran, Iran] from 2006 to 2007. Eligible patients with less than 20 kg of body weight were given 62.5 mg terbinafme and for patients between 20 to 40 kg, the dose was 125 mg, on the first visit. After two weeks, all patients had a second visit that second sample for microscopic study was taken. For each patient, direct mycology test [KOH test] and mycological culture were carried out before the study is being started and after 2[nd], 4[th], 5[th], 6[th] and 8[th] weeks. Drug's probable adverse effects were also recorded. Based on the results of mycological culture of patients' lesions, Microsporum canis and Trichophyton sheonlini were considered as major causes of Tinea capitis in these children. Out of 30 stydy patients, KOH test of 93% in the fifth and 100% in the sixth week, was negative. All patients healed completely from signs of infection, after six weeks. Also, no severe side effects were seen in any patients. According to the results of this study, Terbinafme is an effective therapy in Iranian cases of Tinea capitis in children without having severe side effects