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Aldara
Clinical Pharmacology
Aldara
In a double-blind, placebo-controlled clinical study, 209 otherwise healthy subjects 18 years of age and older with genital/perianal warts were treated with Aldara Cream or vehicle control times per week for a maximum of 16 weeks. The median baseline wart area was 69 mm2 (range 8 to 5525 mm2). Subject accountability is shown in the figure below.
Figure 1: Subject Accountability (External Genital Warts)
 |
Data on complete clearance are listed in the table below. The median time to complete wart clearance was 10 weeks.
Table 14: Complete Clearance Rates (External Genital Warts)- Study EGW1
| Treatment | Subjects with Complete Clearance of Warts |
Subjects Without Follow-up |
Subjects with Warts Remaining at Week 16 |
| Overall | |||
| Aldara Cream (n =109) | 54 (50%) | 19 (17%) | 36 (33%) |
| Vehicle (n =100) | 11 (11%) | 27 (27%) | 62 (62%) |
| Females | |||
| Aldara Cream (n =46) | 33 (72%) | 5 (11%) | 8 (17%) |
| Vehicle (n =40) | 8 (20%) | 13 (33%) | 19 (48%) |
| Males | |||
| Aldara Cream (n =63) | 21 (33%) | 14 (22%) | 28 (44%) |
| Vehicle (n =60) | 3 (5%) | 14 (23%) | 43 (72%) |
Generic Name: Imiquimod
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