Aldara for the Treatment of Large and/or Multiple sBCC

This study has been completed.
Sponsor:
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00189280
First received: September 12, 2005
Last updated: September 24, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Carcinoma, Basal Cell
Drug: Imiquimod
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures:
  • Clinical clearance of sBCC [ Time Frame: 12 or 16 weeks after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction in size of tumour [ Time Frame: 12 or 16 weeks after treatment ] [ Designated as safety issue: Yes ]
  • Rate of clearance, Cosmetic outcome [ Time Frame: 12 or 16 weeks after treatment ] [ Designated as safety issue: Yes ]
  • Sustained clearance rate over 3 year follow-up [ Time Frame: 3 years after treatment ] [ Designated as safety issue: Yes ]
  • Tolerability & QoL [ Time Frame: 12 or 16 weeks after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: May 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: imiqimod 5% cream Drug: Imiquimod
cream 5%, 5 days out of seven, for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189280

Locations
France
Service de DermatologieHôpital Dupuytren
Limoges, France, 87042
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Investigators
Principal Investigator: Professeur Bedane Service de DermatologieHôpital Dupuytren, LIMOGES
  More Information

No publications provided

Responsible Party: Elena Rizova, MD, Medical and Scientific Affairs, Europe & MENA, Laboratoires 3M Santé
ClinicalTrials.gov Identifier: NCT00189280     History of Changes
Other Study ID Numbers: 1475-IMIQ
Study First Received: September 12, 2005
Last Updated: September 24, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by MEDA Pharma GmbH & Co. KG:
Aldara, sBCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on July 23, 2014