Figure 1. Summary of subject enrollment, treatment, and follow-up.

Values are numbers of study subjects. Of the 74 subjects screened, 26 failed screening, most commonly due to having only one lesion that was already substantially healed (17 subjects). Forty-eight subjects were randomized, 24 in each study group. In the polyurethane group, one subject was discontinued due to an unsatisfactory result (enlargement of the index lesion at day 20). In the gauze-and-tape group, two subjects failed to return to the study site and were lost to follow-up. Forty-seven of 48 randomized subjects received a full 20-day course of WR 279,396 as planned in the protocol; one subject in the polyurethane group failed to return for further treatment after day 6.