Imiquimod 5% cream monotherapy for cutaneous squamous cell carcinoma in situ (Bowen's disease): a randomized, double-blind, placebo-controlled trial.
BACKGROUND
We conducted a double-blind, placebo-controlled, randomized trial to evaluate the preliminary efficacy and safety of imiquimod 5% cream treatment for cutaneous squamous cell carcinoma (SCC) in situ.


METHODS
In all, 31 patients with biopsy-proven cutaneous SCC in situ were randomly assigned to placebo (vehicle) (n = 16) or imiquimod 5% cream (n = 15) daily for 16 weeks. Patients were assessed at week 28 for the primary end point, resolution of cutaneous SCC in situ.


RESULTS
Of the 31 patients enrolled, 3 dropped out. Intention-to-treat analysis revealed 11 of the 15 patients (73%) in the imiquimod group achieved resolution of cutaneous SCC in situ, with no relapse during the 9-month follow-up period; none in the placebo group achieved resolution (P < .001). Imiquimod 5% cream was generally well tolerated and there were no serious adverse events.


CONCLUSIONS
Topical imiquimod 5% cream has proven to be an effective treatment for cutaneous SCC in situ. However, studies to define the ideal dosing regimen and cost-effectiveness are required before it can be accepted as a recognized therapy.


CONCLUSIONS
In this controlled trial, patients with cutaneous SCC in situ receiving topical imiquimod 5% cream as monotherapy experienced a high degree of clinical benefit compared with placebo.
Patel
Girish K
GK
Welsh Institute of Dermatology, University Hospital of Wales, Cardiff, United Kingdom. patelgk@cf.ac.uk
Goodwin
Richard
R
Chawla
Maureen
M
Laidler
Peter
P
Price
Patricia E
PE
Finlay
Andrew Y
AY
Motley
Richard J
RJ
D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001913:Bowen's Disease / Q000188:drug therapy*; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy*
D000634:Aminoquinolines; D000970:Antineoplastic Agents; D004304:Dosage Forms; D000077271:Imiquimod