A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma
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To evaluate the long-term sustained clearance rate, defined as the proportion of subjects who are clinically clear of sBCC at the treated sBCC target tumour site at the 12 week posttreatment visit and remain clear during the 5 year follow-up period.
Secondary Outcome Measures :
To evaluate the safety and cosmetic outcome of once daily 5 days per week dosing for 6 weeks with imiquimod 5% cream in the treatment of sBCC
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Have one superficial BCC - primary tumour
Minimum tumour area of 0.5cm2, maximum diameter of 2.0cm.
If female and of child bearing potential, negative pregnancy test and willing to use medically acceptable method of contraception.
Evidence of clinically significant, unstable medical conditions.
Evidence of Gorlin syndrome, metastatic tumour or tumour with high probability of metastatic spread, have or have had within last 5 years other malignant cancers of the skin at target tumour site.
Have received defined treatments in tumour site or surrounding area.
Any dermatological disease in the target tumour site or surrounding area.
Have had a systemic bacterial or viral infection within 2 weeks prior to study initiation.