BACKGROUND:Imiquimod is an immune response modifier that acts through toll-like receptor 7 to induce cytokine production and a subsequent innate and adaptive cell-mediated immune response. Clinical studies have demonstrated clinical and histological clearance of superficial basal cell carcinoma (sBCC) after treatment with imiquimod 5% cream. OBJECTIVES: To evaluate the safety and clinical efficacy of imiquimod (Aldaratrade mark; 3M Pharmaceuticals, St Paul, MN, U.S.A.) 5% cream for the treatment of sBCC in a multicentre, randomized, parallel, vehicle-controlled, double-blind, phase III clinical study conducted at 26 centres in Europe. METHODS: Subjects who had at least onehistologically confirmed sBCC tumour were randomized to apply imiquimod or vehicle cream to the target tumour once daily, seven times per week (7 x/week) for 6 weeks. The target tumour location was identified with an indelible ink mark before treatment initiation. The treated tumour site was clinically assessed for treatment response at 12 weeks post-treatment and was then excised for histological evaluation. Efficacy assessments included the composite response rates (proportion of subjects with clinical and histological clearance) and response rates solely based on histology (proportion of subjects with histological clearance). Safety assessments, which included adverse events and scoring of local skin reactions (LSRs), were carried out throughout the study. RESULTS: In total, 166 subjects were enrolled in this study. For the intent-to-treat dataset, there was a statistically significant difference between imiquimod and vehicle groups for both composite clearance rates (clinical and histological assessments) and histological clearance rates. Composite clearance was demonstrated in 77% and 6% of subjects treated with imiquimod and vehicle cream, respectively. Histological clearance was demonstrated in 80% and 6% of subjects treated with imiquimod and vehicle cream, respectively. The most frequently reported safety findings were investigator-assessed LSRs and spontaneous reports by subjects of application site reactions, which occurred more frequently in the imiquimod group than in the vehicle group. CONCLUSIONS:Imiquimod 5% cream administered 7 x/week for 6 weeks is a safe and effective treatment for sBCC when compared with vehicle cream.
RCT Entities:
BACKGROUND:Imiquimod is an immune response modifier that acts through toll-like receptor 7 to induce cytokine production and a subsequent innate and adaptive cell-mediated immune response. Clinical studies have demonstrated clinical and histological clearance of superficial basal cell carcinoma (sBCC) after treatment with imiquimod 5% cream. OBJECTIVES: To evaluate the safety and clinical efficacy of imiquimod (Aldaratrade mark; 3M Pharmaceuticals, St Paul, MN, U.S.A.) 5% cream for the treatment of sBCC in a multicentre, randomized, parallel, vehicle-controlled, double-blind, phase III clinical study conducted at 26 centres in Europe. METHODS: Subjects who had at least one histologically confirmed sBCC tumour were randomized to apply imiquimod or vehicle cream to the target tumour once daily, seven times per week (7 x/week) for 6 weeks. The target tumour location was identified with an indelible ink mark before treatment initiation. The treated tumour site was clinically assessed for treatment response at 12 weeks post-treatment and was then excised for histological evaluation. Efficacy assessments included the composite response rates (proportion of subjects with clinical and histological clearance) and response rates solely based on histology (proportion of subjects with histological clearance). Safety assessments, which included adverse events and scoring of local skin reactions (LSRs), were carried out throughout the study. RESULTS: In total, 166 subjects were enrolled in this study. For the intent-to-treat dataset, there was a statistically significant difference between imiquimod and vehicle groups for both composite clearance rates (clinical and histological assessments) and histological clearance rates. Composite clearance was demonstrated in 77% and 6% of subjects treated with imiquimod and vehicle cream, respectively. Histological clearance was demonstrated in 80% and 6% of subjects treated with imiquimod and vehicle cream, respectively. The most frequently reported safety findings were investigator-assessed LSRs and spontaneous reports by subjects of application site reactions, which occurred more frequently in the imiquimod group than in the vehicle group. CONCLUSIONS:Imiquimod 5% cream administered 7 x/week for 6 weeks is a safe and effective treatment for sBCC when compared with vehicle cream.
Authors: Mohsen Ibrahim; Davide Scozzi; Kelsey A Toth; Donatella Ponti; Daniel Kreisel; Cecilia Menna; Elena De Falco; Antonio D'Andrilli; Erino A Rendina; Antonella Calogero; Alexander S Krupnick; Andrew E Gelman Journal: J Immunol Date: 2017-12-06 Impact factor: 5.422
Authors: Sylvia Adams; David W O'Neill; Daisuke Nonaka; Elizabeth Hardin; Luis Chiriboga; Kimberly Siu; Crystal M Cruz; Angelica Angiulli; Francesca Angiulli; Erika Ritter; Rose Marie Holman; Richard L Shapiro; Russell S Berman; Natalie Berner; Yongzhao Shao; Olivier Manches; Linda Pan; Ralph R Venhaus; Eric W Hoffman; Achim Jungbluth; Sacha Gnjatic; Lloyd Old; Anna C Pavlick; Nina Bhardwaj Journal: J Immunol Date: 2008-07-01 Impact factor: 5.422
Authors: Gabriela Maria Wiedemann; Severin Johannes Jacobi; Michael Chaloupka; Angelina Krächan; Svetlana Hamm; Stefan Strobl; Roland Baumgartner; Simon Rothenfusser; Peter Duewell; Stefan Endres; Sebastian Kobold Journal: Oncoimmunology Date: 2016-05-31 Impact factor: 8.110
Authors: Susan J Huang; Dirkjan Hijnen; George F Murphy; Thomas S Kupper; Adam W Calarese; Ilse G Mollet; Carl F Schanbacher; Danielle M Miller; Chrysalyne D Schmults; Rachael A Clark Journal: J Invest Dermatol Date: 2009-06-11 Impact factor: 8.551