Table 2.
Trial | Trial phase | Blinding status | Treatments | Sample size, n | Age (SD) | Male, % | Baseline lesion count (SD) | Mean baseline lesion count across treatment arms |
---|---|---|---|---|---|---|---|---|
HDFUDR045 [15] | 2 | Single | 5-FU 4% (4 weeks; OD) | 20 | 65.9 (8.3) | 85 | 11.6 (4.2) | 10.6 |
5-FU 5% (4 weeks; BID) | 20 | 65.2 (11.3) | 95 | 10.5 (3.5) | ||||
Placebo (4 weeks BID) | 20 | 65 (11.8) | 90 | 9.7 (2.2) | ||||
HDFUP3B048 [17] | 3 | Single | 5-FU 4% (4 weeks; OD) | 353 | 67.7 (9.8) | 81 | 14.4 (10.8) | 15.1 |
5-FU 5% (4 weeks; BID) | 349 | 67.4 (10) | 81 | 14.8 (10.6) | ||||
Placebo (4 weeks; OD) | 70 | 68 (10.1) | 83 | 16.2 (15.1) | ||||
HDFUP3S049 [16] | 3 | Double | 5-FU 4% (4 weeks; OD) | 50 | 67.9 (11.7) | 78 | 19.2 (15.0) | 21.2 |
Placebo (4 weeks; OD) | 50 | 66.9 (11.7) | 92 | 23.2 (18.5) | ||||
Krawtchenko 2007 [13] | Unclear | Unclear | 5-FU 5% (4 weeks; BID) | 24 | 70.4 (6.7) | 79 | 8.3 (NR) | 8.1 |
IMQ (4 weeks; TIW) | 26 | 70.8 (5.6) | 85 | 7.9 (NR) | ||||
Weiss 2002 [14] | 3 | Double | 5-FU 0.5% (4 weeks; OD) | 40 | 62.7 (NR) | 75 | 14.1 (8.2) | 15.3 |
Placebo (4 weeks; OD) | 58 | 63.6 (NR) | 95 | 16.4 (11.1) |
BID = twice daily; NR = not reported; OD = once daily; SD = standard deviation; TIW = three times a week.