Aldara for the Treatment of Large and/or Multiple sBCC
- Registration Number
- NCT00189280
- Lead Sponsor
- MEDA Pharma GmbH & Co. KG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description imiqimod 5% cream Imiquimod -
- Primary Outcome Measures
Name Time Method Clinical clearance of sBCC 12 or 16 weeks after treatment
- Secondary Outcome Measures
Name Time Method Reduction in size of tumour 12 or 16 weeks after treatment Sustained clearance rate over 3 year follow-up 3 years after treatment Rate of clearance, Cosmetic outcome 12 or 16 weeks after treatment Tolerability & QoL 12 or 16 weeks after treatment
Trial Locations
- Locations (1)
Service de DermatologieHôpital Dupuytren
🇫🇷Limoges, France