Preparation and Evaluation of Clinical Effects of Glucantime Gel Mask

Abstract

Background: Pentavalent antimony compounds are the main treatment for cutaneous leishmaniasis. Usually, this drug is injected into the lesion for acute treatment, which is very painful and results in low patient compliance. In this study we sought to prepare a topical form of this drug, which is not available in the market. Methods: In this study glucantime gel mask was prepared by using polyvinyl alcohol (PVA), sodium carboxymethylcellulose, and hydroxypropyl methylcellulose as the base polymer and glycerin as the plasticizer. The gel mask was optimized, evaluated for physicochemical properties, and examined on 40 patients with cutaneous leishmaniasis. Patients were randomly divided into control and test groups. All patients received weekly intralesional injection of meglumine antimoniate as routine care. The prepared gel mask was applied twice a day in the test group, and the control group received the placebo gel mask. Findings: PVA was used because its consistency value is better and it causes the rapid release of drug from the base. The optimized formulation showed good physicochemical property. 25 males and 15 females participated in the clinical trial with the mean age of 28.2 years for 6 weeks. There were no significant differences between the two groups in terms of gender, age, and duration of disease. In the test group, 15 patients achieved complete cure at the end of week 6, 2 moderate cure, and 1 mild cure, and 1 patient did not have an acceptable cure. In the control group, 13 patients achieved complete cure and 5 moderate cure, 2 showed no improvement, and in 1 patient the lesion got worse. Conclusion: The gel mask reduces the weekly meglumine antimoniate requirement. This reduction shows the appropriate penetration of the drug from the gel into the lesion.

Keywords

• Meglumine antimoniate
• Gel mask
• Leishmaniasis