Basal Cell Carcinoma
Conditions
Keywords
Aldara, Superficial Basal Cell Carcinoma, Long-Term Study
Brief summary
The purpose of this study is to evaluate the long-term sustained clearance rate of superficial basal cell carcinoma during a 5 year period following treatment with imiquimod
Interventions
DRUGimiquimod
Sponsors
MEDA Pharma GmbH & Co. KG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed