James M Spencer1. 1. Department of Dermatology, Mt. Sinai School of Medicine, New York, NY, USA. jgspencer@tampabay.rr.com
Abstract
BACKGROUND:Curettage and electrodesiccation (C&D) is a widely used method to treat nodular basal cell carcinoma (BCC). However, residual tumor is present immediately after the procedure in approximately 20 to 40% of cases. Imiquimod, a topical immune response modifier that targets Toll-like receptor 7, is currently approved for superficial BCC. OBJECTIVE: In a double-blind, vehicle-controlled study, the administration of imiquimod after C&D was investigated to determine if the combination regimen would reduce the frequency of residual tumor compared with C&D alone in patients with nodular BCC. METHODS:Twenty patients received three cycles of C&D followed by imiquimod 5% or vehicle cream once daily for 1 month as adjunctive therapy. The primary end point was the frequency of residual tumor. The secondary end points included the time to heal and cosmetic appearance. RESULTS:Twenty patients were randomized to the imiquimod (n = 10) or vehicle (n = 10) treatment group. At 8 weeks, the proportion of patients with residual tumor was substantially decreased with imiquimod therapy (10%) compared with vehicle (40%). Wounds in the vehicle group healed more quickly than those in the imiquimod group, although by 8 weeks, all excision sites were healed. The majority of scars in the control group were atrophic and hypopigmented, whereas most scars in the imiquimod group were flat and slightly pink. CONCLUSION:Imiquimod 5% cream once daily for 1 month as adjunctive therapy after C&D substantially reduced the frequency of residual tumor and improved the cosmetic appearance compared with C&D alone. These preliminary results suggest that further studies to investigate imiquimod adjunctive therapy are warranted.
RCT Entities:
BACKGROUND: Curettage and electrodesiccation (C&D) is a widely used method to treat nodular basal cell carcinoma (BCC). However, residual tumor is present immediately after the procedure in approximately 20 to 40% of cases. Imiquimod, a topical immune response modifier that targets Toll-like receptor 7, is currently approved for superficial BCC. OBJECTIVE: In a double-blind, vehicle-controlled study, the administration of imiquimod after C&D was investigated to determine if the combination regimen would reduce the frequency of residual tumor compared with C&D alone in patients with nodular BCC. METHODS: Twenty patients received three cycles of C&D followed by imiquimod 5% or vehicle cream once daily for 1 month as adjunctive therapy. The primary end point was the frequency of residual tumor. The secondary end points included the time to heal and cosmetic appearance. RESULTS: Twenty patients were randomized to the imiquimod (n = 10) or vehicle (n = 10) treatment group. At 8 weeks, the proportion of patients with residual tumor was substantially decreased with imiquimod therapy (10%) compared with vehicle (40%). Wounds in the vehicle group healed more quickly than those in the imiquimod group, although by 8 weeks, all excision sites were healed. The majority of scars in the control group were atrophic and hypopigmented, whereas most scars in the imiquimod group were flat and slightly pink. CONCLUSION:Imiquimod 5% cream once daily for 1 month as adjunctive therapy after C&D substantially reduced the frequency of residual tumor and improved the cosmetic appearance compared with C&D alone. These preliminary results suggest that further studies to investigate imiquimod adjunctive therapy are warranted.