Topical imiquimod can reverse vulvar intraepithelial neoplasia: a randomised, double-blinded study.
OBJECTIVE
To investigate the effect of topical imiquimod in patients with vulvar intraepithelial neoplasia (VIN).


METHODS
We used a prospective, randomised, double-blinded, placebo-controlled study. Women with biopsy verified, visible VIN2 or VIN3, in a biopsy not older than 2 months were considered.


RESULTS
Thirty-two patients were included, one was excluded before treatment. Twenty-one received active treatment, 10 received placebo. Seventeen (81%) in the treatment group showed complete response, two (10%) partial response and none responded in the placebo-group when evaluated by a biopsy 2 months after a treatment period of 16 weeks. Fourteen of 21 patients (67%) in the treatment group had to reduce the number of applications due to local side-effects.


CONCLUSIONS
The topical treatment with imiquimod 5% was shown in this setting to be very efficient. Local side effects were a common feature, but tolerable after dose reduction. Long-term results are not known, but a planned cohort study of this population will show the rate of recurrences.
Mathiesen
Ole
O
Department of Gynaecology, University Hospital of Aarhus, Skejby, DK-8200 Aarhus N, Denmark. OMA@sks.aaa.dk
Buus
Sanne K
SK
Cramers
Marie
M
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002278:Carcinoma in Situ / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced; D011446:Prospective Studies; D016896:Treatment Outcome; D014846:Vulvar Neoplasms / Q000188:drug therapy*
D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod