Topical application of Veregen® is relatively well tolerated by patients
Patients were advised to apply the ointment three times daily for 16 weeks. Nineteen patients remained on treatment for 16 weeks, 10 in the placebo arm and 9 in the Veregen® arm. Percentage administered, taking into account both reductions and interruptions was determined for each patient, the Veregen® arm had mean percentage administered of 69.94% in contrast to the placebo arm with 86.43%.
Overall, there was a higher number of patients who reduced the frequency of ointment application in the Veregen® group compared to the placebo group; 52 dose reductions in 11 patients and 70 dose reductions in 12 patients, respectively. Concomitant medications such as Paracetamol, NSAIDs and 1% topical lignocaine ointment were permitted to be used along Veregen®/placebo treatment to help alleviate symptoms caused by either the trial medication or uVIN. At baseline, only three patients in Veregen® group were using concomitant medication and none in the placebo group. On trial, 2 patients on the placebo arm used paracetamol and Sudocrem, respectively, whilst on the Veregen® arm, 7 patients used lignocaine with and one patient also took oral simple analgesia for pain control.
The adverse effects which relate to the use of trial ointments are detailed in Table 2. Baseline uVIN symptoms reported prior to starting trial medications were burning, erythema multiforme, pain and pruritus, with itchiness being the most typical symptoms. In one patient, the severity of erythema multiforme was reported as grade 4. Overall, most adverse events reported were grade 1, 89% in placebo and 74% in Veregen® group. Grade 3 and 4 adverse events were only reported in Veregen® group and collectively, only two patients suffered from such symptoms. One of the patients who reported a grade 4 adverse event was presented with underlying grade 4 erythema multiforme. The other patient who complained of a grade 3 adverse event had a burning sensation. One patient did not report any adverse events, she was in the placebo group. There was a single serious adverse event, reported in the Veregen® group, with upper respiratory symptoms who was subsequently diagnosed as lower respiratory tract infection, an even unrelated to Veregen® toxicity. Supplementary Table 1 lists the adverse effects reported with the application of Veregen® and placebo. All adverse effects experienced by the patients were fully resolved to baseline upon stopping the medication