Aldara for the Treatment of Large and/or Multiple sBCC
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.
1 other identifier
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFebruary 22, 2022
September 1, 2008
4.4 years
September 12, 2005
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical clearance of sBCC
12 or 16 weeks after treatment
Secondary Outcomes (4)
Reduction in size of tumour
12 or 16 weeks after treatment
Rate of clearance, Cosmetic outcome
12 or 16 weeks after treatment
Sustained clearance rate over 3 year follow-up
3 years after treatment
Tolerability & QoL
12 or 16 weeks after treatment
Study Arms (1)
imiqimod 5% cream
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- One or more sBCC on torso, neck or face
- Total surface area \<= 40 sq cm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de DermatologieHôpital Dupuytren
Limoges, 87042, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professeur Bedane
Service de DermatologieHôpital Dupuytren, LIMOGES
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
May 1, 2003
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
February 22, 2022
Record last verified: 2008-09