Ta. Syed et al., HUMAN-LEUKOCYTE INTERFERON-ALPHA IN CREAM, FOR THE TREATMENT OF GENITAL WARTS IN ASIAN WOMEN - A PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY, The Clinical investigator, 72(11), 1994, pp. 870-873
The purpose of this double-blind, placebo-controlled study was to dete
rmine and compare the clinical efficacy and tolerance of human leukocy
te alpha-interferon (incorporated 2 x 10(6) IU/g) in hydrophilic cream
to cure genital warts. Preselected Asian female patients (n = 150) ag
ed 18-40 years (mean 22.5), with the clinical and biopsy-confirmed dia
gnosis of genital warts (mean 2.64), predominantly flat vaginal condyl
omas, were randomly allocated to 3 parallel groups. Each patient was g
iven a coded tube containing 80 g placebo/active preparation with a gr
aduated applicator. Patients were instructed to inject 6 g of the eith
er alloted placebo/active cream deep into the vagina thrice a day for
3 consecutive days (group A) or 4 consecutive days (group B) per week,
and if not cured the same treatment was extended to 3 more weeks (max
imum 4 weeks active treatment). To assess the clinical efficacy patien
ts were examined on a week-to-week basis. A total clearance of warts (
biopsy-confirmed) was evaluated as a complete cure. Patients cured dur
ing the treatment were spared further treatment and were requested to
visit us after 16 weeks for relapse control. As for the remaining pati
ents, empty tubes were collected, and similarly coded replacement tube
s were given for further treatment (in total 588 tubes were used). By
the end of the treatment 57.2% lesions (227/397) were eliminated in al
l the groups: 48% patients in group A, 90% patients in group B, and 10
% patients in placebo groups taken as completely cured. Of the 150 pat
ients 128 (85.3%) did not complain of any drug-related adverse symptom
s. Transitory increase in body temperature (mean 38.4 degrees C), acco
mpanied by headache (14.6%) and generalized itching (6.6%) were the mo
st frequently reported side effects; however, treatment was well toler
ated by all the patients, and there were no dropouts. Our findings ind
icate that clinical efficacy is dose dependent, that is, the results o
f group B were significantly superior to that of group A (P < 0.05). O
f the 49.3% cured patients (74/150) followed up for 6 months (monthly
basis) seven had a relapse, and none had reinfection. It is concluded
that clinical efficacy of leukocyte interferon-alpha to cure genital w
arts is dose dependent. These results further support the view that le
ukocyte interferon-alpha incorporated in hydrophilic cream can be cons
idered a reliable, safe, and home-based treatment to cure vulvar and v
aginal warts.