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