Aldara for the Treatment of Large and/or Multiple sBCC

Meda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Basal Cell

Treatments: Drug: Imiquimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189280

1475-IMIQ

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

imiqimod 5% cream

Experimental group

Treatment:

Drug: Imiquimod