Imiquimod 3.75% Cream Applied Daily to Treat Anogenital Warts: Combined Results from Women in Two Randomized, Placebo-Controlled Studies

Table 2

Anatomic site-specific clearance rates, per protocol population.

Women	Placebo	Imiquimod 2.5%	Imiquimod 3.75%
	87	151	153
Anatomic site complete clearance, 𝑛/N ^a (%)
Vulvar	14/51 (27.5)	42/98 (42.9)	53/104 (51.0)^b
Inguinal	2/9 (22.2)	4/18 (22.2)	9/20 (45.0)
Perineal	11/43 (25.6)	36/68 (52.9)	48/74 (64.9)^b
Perianal	10/40 (25.0)	34/69 (49.3)^b	51/65 (78.5)^b,c
Change in wart count from baseline, mean percent (standard deviation)
Vulvar	−23.8 (56.4)	−52.3 (55.6)^d	−56.8 (75.8)^d
Inguinal	−27.2 (60.1)	−14.4 (69.5)	−49.3 (54.2)
Perineal	−21.3 (62.5)	−61.8 (46.1)^d	−74.6 (42.9)^d
Perianal	−11.6 (96.4)	−52.7 (59.5)^d	−82.2 (40.4)^d,e

^a N is women with anatomic site involved.
^bStatistically significant versus placebo using Hochberg's modified Bonferroni procedure with 𝑃 value determined by Cochran-Mantel-Haenszel test, stratified by analysis site two treatment groups at a time.
^cStatistically significant versus imiquimod 2.5% using Hochberg's modified Bonferroni procedure with 𝑃 value determined by Cochran-Mantel-Haenszel test, stratified by analysis site two treatment groups at a time.
^dStatistically significant versus placebo using Hochberg's modified Bonferroni procedure with 𝑃 value determined by ANCOVA with main effect treatment and controlling for baseline lesion count and analysis site.
^eStatistically significant versus imiquimod 2.5% using Hochberg's modified Bonferroni procedure with 𝑃 value determined ANCOVA with main effect treatment and controlling for baseline lesion count and analysis site.