The 3.75% strength of Zyclara topical cream is approved by the FDA to treat external gential and anal area (perianal) warts in people 12 years of age and older, but does not work for everyone. Zyclara is not a cure for genital warts and may not completely clear your warts.

You may still spread this condition to others through vaginal, anal, or oral sex. You also may develop new lesions during treatment.

How is Zyclara applied for genital warts?

For the treatment of genital warts, topical Zyclara (imiquimod) cream 3.75% is applied once daily for up to 8 weeks. Topical medicine should only be used on the skin. Follow your doctor’s instructions exactly. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

How well did Zyclara work in studies for gential warts?

In two double-blind, randomized, placebo-controlled clinical studies, 601 subjects with external gential warts were treated with 3.75% Zyclara cream or a matching placebo (inactive) vehicle cream.

Up to one packet of study cream was applied once daily. The cream was applied to warts areas before bedtime and left on for about 8 hours for up to 8 weeks or until complete clearance of all warts. Complete clearance was defined as clearance of all warts in all areas within 16 weeks from the beginning of treatment.

• In study 1, 53/195 (27%) of patients receiving Zyclara cream achieved complete clearance compared to 10/97 (10%) of those receiving the placebo vehicle cream.
• In study 2, 60/204 (29%) of patients receiving Zyclara cream achieved complete clearance compared to 9/105 (9%) of those receiving the placebo vehicle cream.
• In the combined studies, 79/216 (37%) of females on the 3.75% Zyclara formulation achieved complete clearance compared to 34/183 (19%) of males.
• Of the 113 subjects who used Zyclara cream and achieved complete clearance in both studies, 17 (15%) subjects had a return of genital warts within 12 weeks.