In two double-blind, vehicle-controlled clinical studies, 364 subjects with primary sBCC were treated with Aldara Cream or vehicle cream 5 times per week for 6 weeks. click here to buy aldara cream over the counter Target tumors were biopsy-confirmed sBCC and had a minimum area of 0.5 cm 2 and a maximum diameter of 2.0 cm (4.0 cm 2 ). Target tumors were not to be located within 1.0 cm of the hairline, or on the anogenital area or on the hands or feet, or to have any atypical features. The population ranged from 31–89 years of age (median 60 years) and 65% had Fitzpatrick skin type I or II. On a scheduled dosing day, study cream was applied to the target tumor and approximately 1 cm (about 1/3 inch) beyond the target tumor prior to normal sleeping hours, and 5 times per week dosing was continued for a total of 6 weeks. The target tumor area was clinically assessed 12 weeks after the last scheduled application of study cream. The entire target tumor was then excised and examined histologically for the presence of tumor.
Efficacy was assessed by the complete response rate defined as the proportion of subjects with clinical (visual) and histological clearance of the sBCC lesion at 12 weeks post-treatment. Of Aldara treated subjects, 6% (11/178) who had both clinical and histological assessments post-treatment, and who appeared to be clinically clear had evidence of tumor on excision of the clinically-clear treatment area.
Data on composite clearance (defined as both clinical and histological clearance) are shown in the following table.
A separate 5-year, open-label study was conducted to assess the recurrence of sBCC treated with Aldara Cream applied once daily 5 days per week for 6 weeks. Target tumor inclusion criteria were the same as for the studies described above. At 12-weeks post-treatment, subjects were clinically evaluated for evidence of persistent sBCC (no histological assessment). Subjects with no clinical evidence of sBCC entered the long-term follow-up period. At the 12 week post-treatment assessment, 90% (163/182) of the subjects enrolled had no clinical evidence of sBCC at their target site and 162 subjects entered the long-term follow-up period for up to 5 years. Two year (24 month) follow-up data are available from this study and are presented in the table below:
Topical overdosing of Imiquimod Cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions.
Hypotension was reported in a clinical trial following multiple oral imiquimod doses of >200 mg (equivalent to ingestion of the imiquimod content of more than 21 packets or pump actuations of Imiquimod Cream, 3.75% or more than 32 pump actuations of Imiquimod Cream, 2.5%). The hypotension resolved following oral or intravenous fluid administration.
Treatment of plantar warts is often difficult and may be painful, often employing destructive treatment modalities. http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20723s11s12lbl.pdf We report the successful treatment of a patient with a large plantar wart using Imiquimod 5% cream under occlusion with a 40% salicylic acid pad. This combination treatment modality likely allows successful delivery of Imiquimod through the thick skin on the plantar surface. Once penetrated, an anti-viral state is created by upregulating specific cytokines to eradicate the human papilloma virus (HPV).