drugset / Trial / NCT00128323

A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis

NCT00128323

RandomizedParallel-groupDouble-blindTreatment

Summary

In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems. In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin. GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem. In this study of children, the investigators have compared the 3 solutions, 1% GV, 0.00165% GV and nystatin oral drops - all masked so that they look the same - to see if GV is more effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.

Timeline

Start
2002-11
Primary completion
Completion
2005-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HEXAMETHYL PARAROSANILINE Small molecule 0.00165 % Oral
Subject HEXAMETHYL PARAROSANILINE Small molecule 1 % Oral
Subject Nystatin Unknown 1 ml Oral

Indications