Overview

Aldara for the Treatment of Large and/or Multiple sBCC

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Treatments:
Imiquimod
Criteria
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