Carcinoma, Basal Cell
Conditions
Keywords
Aldara, sBCC
Brief summary
BCC is the most common form of skin cancer. Current treatment is often surgery but this can be limited by the number of lesions, their location the age of the patient or the potential cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on a non surgical treatment, in subjects with multiple of large sBCCs.
Interventions
DRUGImiquimod
cream 5%, 5 days out of seven, for 6 weeks
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
* One or more sBCC on torso, neck or face * Total surface area \<= 40 sq cm
Exclusion criteria
* Pregnancy or women who are breastfeeding * Xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors * Metatypical, adnexal, or sclerodermiform carcinomas * Current or other previous malignant skin tumor (epidermoid carcinoma, melanoma) in the region of the current lesion * Known HIV positive serology * Skin tumor that is already or highly likely to become metastatic * Presence of a clinically significant anomaly or illness (immunological, cardiovascular, pulmonary, hematological, neurological, hepatic, renal, endocrine, gastrointestinal, collagenous) * Previous organ transplant history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical clearance of sBCC | 12 or 16 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in size of tumour | 12 or 16 weeks after treatment |
| Rate of clearance, Cosmetic outcome | 12 or 16 weeks after treatment |
| Sustained clearance rate over 3 year follow-up | 3 years after treatment |
| Tolerability & QoL | 12 or 16 weeks after treatment |
Countries
France
Outcome results
None listed