Back to resultsAldara for the Treatment of Large and/or Multiple sBCC
Primary Purpose
Carcinoma, Basal Cell
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Imiquimod
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Basal Cell focused on measuring Aldara, sBCC
Eligibility 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
Sites / Locations
- Service de DermatologieHôpital Dupuytren
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
imiqimod 5% cream
Arm Description
Outcomes
Primary Outcome Measures
Clinical clearance of sBCC
Secondary Outcome Measures
Reduction in size of tumour
Rate of clearance, Cosmetic outcome
Sustained clearance rate over 3 year follow-up
Tolerability & QoL
Full Information
NCT ID
NCT00189280
First Posted
September 12, 2005
Last Updated
February 4, 2022
Sponsor
MEDA Pharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00189280
Brief Title
Aldara for the Treatment of Large and/or Multiple sBCC
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MEDA Pharma GmbH & Co. KG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Basal Cell
Keywords
Aldara, sBCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
imiqimod 5% cream
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Intervention Description
cream 5%, 5 days out of seven, for 6 weeks
Primary Outcome Measure Information:
Title
Clinical clearance of sBCC
Time Frame
12 or 16 weeks after treatment
Secondary Outcome Measure Information:
Title
Reduction in size of tumour
Time Frame
12 or 16 weeks after treatment
Title
Rate of clearance, Cosmetic outcome
Time Frame
12 or 16 weeks after treatment
Title
Sustained clearance rate over 3 year follow-up
Time Frame
3 years after treatment
Title
Tolerability & QoL
Time Frame
12 or 16 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professeur Bedane
Organizational Affiliation
Service de DermatologieHôpital Dupuytren, LIMOGES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de DermatologieHôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Learn more about this trial
Aldara for the Treatment of Large and/or Multiple sBCC
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