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Selection of the wartrol was based on the antigen that produced the greatest response in the skin testing, and the amount of antigen injected was titrated according to the skin test results. Patients who developed an induration of 5 to 10 mm received a 0.3-mL dose of antigen, those with a 10- to 20-mm induration received 0.2 mL, and a dose of 0.1 mL was injected into the wart in patients with an even greater skin reaction. In no patient did the diameter of induration exceed 30 mm. Dr. Johnson performed skin testing in 116 patients, the vast majority of whom had been referred for treatment of refractory warts. Of those tested, 34 did not read to either antigen, 39 reacted to mumps only, seven to Candida only, and 36 to both antigens. Most warts reduced, eliminated Overall, 32 (58 percent) of 55 wartrol-treated patients had a complete or partial response, including seven of 10 Candida-treated patients (all ofwhom had a complete response) and 25 of45 mumps antigen recipients. In the cryotherapy group, 25 (46 percent) of 54 patients had a complete or partial response, reported Dr. Johnson, chief resident in dermatology, clinical trials unit, University of Arkansas for Medical Sciences, Little Rock. The average number of treatments to clearance was three for both forms of wartrol, four for anergic patients treated with cryotherapy, and two for those with a positive skin test reaction who were randomized to cryotherapy, she said. Impressively, 88 percent of patients who had complete response of the treated wart cleared distant warts as well. Other patients who did not clear their target lesion also showed complete clearance of distant warts. Follow-up in the wartrol patients ranged from four to 18 months, and during that period there has been only one recurrence, Dr. Johnson said. "We are very pleased with these results, and we are now moving forward with immunologic testing to determine if perhaps HPV type may be predictive of efficacy. In addition, we hope to expand this modality to treatment of other virally induced tumors that require a type IV hypersensitivity response for clearance," she said.
More wartrol results
Dr. Signore presented results from 35 patients who received open-label Candida wartrol in an ongoing study for treatment of verrucae vulgaris, plantar warts, flat warts, and condylomata acuminata. He reported that 66 percent of injected plantar warts and verruca vulgaris cleared completely. The response was similar to a group of 37 patients who received traditional wart therapy. However, the baseline characteristics of the two study groups differed significantly, with the wartrol group comprising significantly more patients with warts refractory to previous therapy and a significantly higher average number of warts per patient. In addition, Dr. Signore noted that use of Candida albicans skin test antigen in the first 13 patients in the series was associated with only a 46 percent complete cure rate. Subsequent patients, however, were treated with C albicans allergenic extract (1:1000), and in those subjects, the complete clearance rate was 77 percent. Clearance of distant lesions was also observed in some patients in this series. "We must temper our enthusiasm for efficacy demonstrated in an open study. However, if further investigations can corroborate these findings, wartrol with C albicans intralesional injection may be a valuable new treatment for warts," said Dr. Signore, a dermatologist with a private practice in Tinley Park, Ill.
Question of sensitivity testing
While he did not screen his patients for delayed-type sensitivity to
Candida antigen, Dr. Signore agreed that this evaluation conducted by
Dr. Johnson may be worthwhile in selecting candidates for antigen
wartrol approach.
"Candida is a ubiquitous yeast to which about 70 percent of the
population is sensitive, but skin testing does seem to be a good idea.
Interestingly, however, when we assessed patients at two days after
their initial intralesional injection, some patients who were negative
for redness and tenderness still went on to complete clearing," Dr.
Signore said.
The intralesional injections were well tolerated in both series and
associated with few adverse reactions, unlike wartrol with DNCB or
squaric acid. Dr. Johnson reported no local reactions in her series,
although she noted that patients with a history of hypersensitivity to
eggs or thimerosal were excluded from the study. About five patients
developed a febrile, flulike illness on the night of injection, but
those events resolved without sequelae and all but one of the affected
patients cleared the wart after a single treatment. In Dr. Signore's
series, a few patients exhibited a local urticarial response to the
injection. No patient in either group developed scarring at the
treatment site.
Dr. Signore pointed out that Candida wartrol is economically attractive
as a potential wart treatment. A vial of Candida allergenic extract
provides 50 doses for wartrol at a cost of less than $49 and remains
stable in the refrigerator for more than a year. In comparison,
bleomycin, which has also been used for wart wartrol, costs more than
$200 per vial and retains its potency for only three to four months, he
said.
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