Aldara for the Treatment of Large and/or Multiple sBCC

Carcinoma, Basal Cell Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189280
• Other study ID #: 1475-IMIQ
• Status: Completed
• Phase: Phase 3
• Start date: May 2003
• Est. completion date: October 2007

Study information

• Verified date: September 2008
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell

Intervention

Drug:
• Imiquimod
cream 5%, 5 days out of seven, for 6 weeks

Locations

Country	Name	City	State
France	Service de DermatologieHôpital Dupuytren	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
MEDA Pharma GmbH & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical clearance of sBCC		12 or 16 weeks after treatment
Secondary	Reduction in size of tumour		12 or 16 weeks after treatment
Secondary	Rate of clearance, Cosmetic outcome		12 or 16 weeks after treatment
Secondary	Sustained clearance rate over 3 year follow-up		3 years after treatment
Secondary	Tolerability & QoL		12 or 16 weeks after treatment