PurposeMalignant fungating tumors are neoplastic tumors associated with skin ulcers, which are susceptible to microbial colonization. Bacterial infection and proliferation may lead to malodor causing distress to patients. Metronidazole—an effective agent against anaerobes—may contribute to deodorization and improvement in quality of life (QOL). This study investigated the efficacy and safety of topical metronidazole 0.75 % gel for alleviation of malodor in anaerobically infected fungating neoplastic tumors.MethodsThis was a multicenter, open-label, non-controlled, phase III study including subjects aged 20 years or older with cutaneous fungating tumors releasing malodor (minimum score of 2 (mildly offensive smell) on a scale from 0 (no smell) to 4 (extremely offensive smell) based on investigator’s assessment). Subjects applied metronidazole 0.75 % gel once or twice daily at the investigator’s discretion for 14 days. Success was defined as an odor score of 0 or 1 at day 14, as assessed by the investigator. Patient satisfaction was assessed using a satisfaction questionnaire. Adverse events (AEs) that occurred after application of metronidazole 0.75 % gel were also reported.ResultsA total of 21 subjects at a median age of 65.0 years were enrolled. The success rate of deodorization at day 14 was 95.2 % (20/21 subjects). The patient satisfaction assessment showed that 71.4 % (15/21) of subjects were markedly or moderately improved. The treatment was well tolerated with only two AE cases of skin neoplasm bleeding (one mild and one moderate).ConclusionsMetronidazole 0.75 % gel is an effective and safe treatment for deodorization of malodorous fungating tumors.

No abstract

The cytotoxicity test using MTT on HeLa cells (HeLa-MTT) was evaluated as an alternative method to the Draize eye irritation test (Draize test) by six to eight laboratories. The 50% inhibition concentration (EC(50)) for MTT reduction was calculated. A total of thirty-nine test chemicals were examined. The average interlaboratory coefficient of variation (CV) of the present assay was 25%. Comparison of the in vitro test results with those of the Draize test revealed a correlation coefficient of -0.799 between the log(EC(50)) value and the maximum average total score (MAS) for a 10% solution or suspension. The following characteristics of HeLa-MTT have become apparent through this validation: (1) HeLa-MTT could be applied to all substances including water-insoluble substances, esters, a colour additive, and a substance which is known to directly reduce MTT; (2) there is good interlaboratory reproducibility and strong correlation between HeLa-MTT and Draize MAS; (3) results for strong acids, alkanolamines and alcohols (lower mono-ol) clearly deviate from other samples with respect to the correlation between HeLa-MTT and Draize MAS. These results suggest that HeLa-MTT may be useful for predicting the Draize MAS if definite criteria can be established for applicable compounds.

No abstract