Kr. Beutner et al., TREATMENT OF GENITAL WARTS WITH AN IMMUNE-RESPONSE MODIFIER (IMIQUIMOD), Journal of the American Academy of Dermatology, 38(2), 1998, pp. 230-239
Background: Genital warts are a common sexually transmitted disease ca
used by human papillomavirus. Imiquimod is a novel immune-response mod
ifier capable of inducing a variety of cytokines, including interferon
alfa, tumor necrosis factor-alpha, as well as interleukins 1, 6, and
8. In animal models imiquimod has demonstrated antiviral, antitumor, a
nd adjuvant activity. In vitro, imiquimod has no antiviral or antitumo
r activity. Objective: Our purpose was to determine the safety and eff
icacy of topical imiquimod for the treatment of external genital warts
. Methods: This prospective double-blind, placebo-controlled, parallel
design clinical trial was performed in three outpatient centers, a pu
blic health clinic, a university-based clinic, and a private practice.
One hundred eight patients with external genital wafts (predominantly
white men) were entered into the trial. Fifty-one patients were rando
mly selected to receive 5% imiquimod cream; 57 patients were randomly
chosen to receive placebo cream. Study medication was applied three ti
mes weekly for up to 8 weeks. Patients whose warts cleared completely
were observed for up to 10 weeks to determine recurrence rates. Result
s: In the intent-to-treat analysis, the warts of 37% (19 of 51) of the
imiquimod-treated patients and 0% (0 of 57) of the placebo group clea
red completely (p < 0.001). In addition, many patients experienced a p
artial response. A reduction in baseline wart area of 80% or more was
observed in 62% of imiquimod-treated patients (28 of 45) and 4% of the
placebo group (2 of 50) (p < 0.001); a 50% reduction or more in wart
area was noted in 76% of imiquimod-treated patients (34 of 45) and 8%
of placebo recipients (4 of 50) (p < 0.001). Of imiquimod-treated pati
ents whose warts cleared completely and who finished the 10-week follo
w-up period. 19% (3 of 16) experienced recurrences of warts. Imiquimod
-treated patients experienced a significantly greater number of local
inflammatory reactions than the placebo group. Symptoms and signs asso
ciated with the local inflammatory reactions included itching (54.2%),
erythema (33.3%), burning (31.3%), irritation (16.7%), tenderness (12
.5%), ulceration (10.4%), erosion (10.4%), and pain (8.3%). There were
no differences in systemic reactions or laboratory abnormalities betw
een treatment groups. Conclusion: Topical 5% imiquimod cream appears t
o have a significant therapeutic effect in the treatment of external g
enital warts.