Open Study to Evaluate the Efficacy and Tolerance of Imiquimod 5% Cream for the Treatment of a Large and/or Multiple Superficial Basal Cell Carcinoma.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Basal Cell
Both
Carcinoma, Basal Cell
Trial Information
Open Study to Evaluate the Efficacy and Tolerance of Imiquimod 5% Cream for the Treatment of a Large and/or Multiple Superficial Basal Cell Carcinoma.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical clearance of sBCC
Outcome Time Frame:
12 or 16 weeks after treatment
Safety Issue:
Yes
Principal Investigator
Professeur Bedane
Investigator Role:
Principal Investigator
Investigator Affiliation:
Service de DermatologieHôpital Dupuytren, LIMOGES
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
1475-IMIQ
NCT ID:
NCT00189280
Start Date:
May 2003
Completion Date:
October 2007
Related Keywords:
- Carcinoma, Basal Cell
- Aldara, sBCC
- Carcinoma
- Carcinoma, Basal Cell
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