A randomized, double-blinded, placebo-controlled, multicenter, efficacy and safety study of 3.75% imiquimod cream following cryosurgery for the treatment of actinic keratoses.
OBJECTIVE
Evaluate cryosurgery followed by 3.75% imiquimod cream to treat actinic keratoses (AK).


METHODS
Adults with > or =10 AKs on the face underwent cryosurgery of five to 14 lesions. Subjects with > or =5 lesions remaining were randomized to 3.75% imiquimod or placebo cream applied to the entire face daily for two two-week cycles. Efficacy was assessed through week 26.


RESULTS
For the cryosurgery/3.75% imiquimod (n=126) and cryosurgery/placebo (n=121) groups, respectively, median total AK reductions were 86.5 and 50 percent, and proportions of subjects with complete clearance were 30.2 and 3.3 percent (P < 0.0001, both). Analyzing cryosurgery-treated lesions only, median reductions were 100 and 80 percent (P = 0.0008), and subject complete clearance rates were 59.5% and 29.8% (P < 0.001), respectively. Only one subject discontinued for a treatment-related adverse event (cryosurgery/3.75% imiquimod group).


CONCLUSIONS
Cryosurgery was performed per usual study center practice and not standardized.


CONCLUSIONS
A short, cyclical treatment course of field-directed daily 3.75% imiquimod cream following lesion-directed cryosurgery was well tolerated and provided additional therapeutic benefits to cryosurgery alone.
Jorizzo
Joseph L
JL
Department of Dermatology, Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, NC, USA.
Markowitz
Orit
O
Lebwohl
Mark G
MG
Bourcier
Marc
M
Kulp
James
J
Meng
Tze-Chiang
TC
Levy
Sharon
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018592:Cross-Over Studies; D003452:Cryosurgery; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077271:Imiquimod; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055623:Keratosis, Actinic / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D012959:Socioeconomic Factors
D000634:Aminoquinolines; D007166:Immunosuppressive Agents; D009824:Ointments; D000077271:Imiquimod