Aldara for the Treatment of Large and/or Multiple sBCC

Phase 3

Completed

• Conditions: Carcinoma, Basal Cell
• Interventions: Drug: Imiquimod

• 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

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-09
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-22

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