A pseudo-randomised clinical trial of in situ gels of fluconazole for the treatment of oropharngeal candidiasis.
Author(s): Nairy HM, Charyulu NR, Shetty VA, Prabhakara P
Affiliation(s): Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte Post, Mangalore, India. firstname.lastname@example.org
Publication date & source: 2011-04-19, Trials., 12:99.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
BACKGROUND: Oropharyngeal candidasis is a common opportunistic infection seen in immunocompromised patients. Fluconazole has a broad spectrum antifungal activity including a wide variety of candida species. Aim of the present investigation was to formulate and find out the relative efficacy of in situ gels of fluconazole. METHOD: The in situ gels were prepared using polymers which exhibited sol-to-gel phase transition due to change in specific physico-chemical parameters, such as ion triggered system using gellan gum (0.5% w/v) along with sodium carboxylmethylcellulose (0.35%w/v). The study design was bicenter, 'pseudo-randomised, single blind trial conducted in Mangalore., India, which includes 15 HIV positive patients, 15 patients with partial or completes dentures, and 15 patients who were treated with (active control) fluconazole tablets 100 mg/day for 14 days. Severity of disease was scored clinically before treatment and at clinical evaluations on day 3, 7, 14, 18, 21, 35, and 42. Semiquantitative microbiological cultures of oral swabs were also obtained on same days. RESULTS: All patients had mycological documented oropharyngeal candidiasis and were treated with fluconazole (0.5%w/v) in situ gels for 14 days Severity of disease was scored clinically before treatment and at different predetermined time intervals along with semi quantitative culture of oral swabs. The clinical response rate showed 97% cure after 14 days in the treated with in situ gel. In comparison, the control group treated with fluconazole tablets showed 85% improvement in symptoms of oral candidiasis. The patients suffering from HIV infection showed relapse in oral candidiasis at the end of 21 days. The patients having oral candidiasis due to partial or complete dentures showed complete recovery and were free from signs and symptoms of oral candidiasis. CONCLUSIONS: The in situ gel formulation of fluconazole was well tolerated with no severe adverse reaction and offers a better alternative to tablet formulation in the treatment of oropharyngeal candidasis. TRIAL REGISTRATION: Current Controlled Trails ISRCTN90634047.