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ALDARA CREAM (IMIQUIMOD): CLINICAL STUDIES
In two double-blind, vehicle-controlled clinical studies, 436 subjects with AK were randomized to treatment with either Imiquimod (Aldara) or vehicle cream 2 times per week for 16 weeks. The studies enrolled subjects with 4 to 8 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions within a 25 cm2 contiguous treatment area on either the face or scalp. The 25 cm2 contiguous treatment area could be of any dimensions e.g., 5 cm x 5 cm, 3 cm by 8.3 cm, 2 cm by 12.5 cm. Study subjects ranged from 37 to 88 years of age (median 66 years) and 55% had Fitzpatrick skin type I or II. All Aldara-treated subjects were Caucasians.
On a scheduled dosing day, the study cream was applied to the entire treatment area prior to normal sleeping hours and left on for approximately 8 hours. Twice weekly dosing was
continued for a total of 16 weeks. The clinical response of each subject was evaluated 8 weeks after the last scheduled application of study cream. Efficacy was assessed by the complete clearance rate, defined as the proportion of subjects at the 8-week post-treatment visit with no (zero) clinically visible AK lesions in the treatment area. Complete clearance included clearance of all baseline lesions, as well as any new or sub-clinical AK lesions which appeared during therapy.
Complete and partial clearance rates are shown in the table below. The partial clearance rate was defined as the percentage of subjects in whom 75% or more baseline AK lesions were cleared.
Sub-clinical AK lesions may become apparent in the treatment area during treatment with Aldara (Imiquimod) cream. During the course of treatment, 48% (103/215) of subjects experienced an increase in AK lesions relative to the number present at baseline within the treatment area. Subjects with an increase in AK lesions had a similar response to those with no increase in AK lesions.
Superficial Basal Cell Carcinoma
In two double-blind, vehicle-controlled clinical studies, 364 subjects with primary sBCC were treated with Aldara (Imiquimod) topical cream or vehicle cream 5 times per week for 6 weeks. Target tumors were biopsy-confirmed sBCC and had a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm (4.0 cm2). 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 posttreatment, and who appeared to be clinically clear had evidence of tumor on excision of the clinically-clear treatment area.
A separate 5-year, open-label study was conducted to assess the recurrence of sBCC treated with Aldara (Imiquimod) cream 5% 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 Posttreatment 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.
External Genital Warts
In a double-blind, placebo-controlled clinical study, 209 otherwise healthy subjects 18 years of age and older with genital / perianal warts were treated with Imiquimod (Aldara) cream or vehicle control 3 times per week for a maximum of 16 weeks. The median baseline wart area was 69 mm2 (range 8 to 5525 mm2).
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|Retinide - Isotretinoin
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