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Aldara for the Treatment of Large and/or Multiple sBCC

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ClinicalTrials.gov Identifier: NCT00189280
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell Drug: Imiquimod Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

Arm Intervention/treatment
Experimental: imiqimod 5% cream Drug: Imiquimod
cream 5%, 5 days out of seven, for 6 weeks



Primary Outcome Measures :
  1. Clinical clearance of sBCC [ Time Frame: 12 or 16 weeks after treatment ]

Secondary Outcome Measures :
  1. Reduction in size of tumour [ Time Frame: 12 or 16 weeks after treatment ]
  2. Rate of clearance, Cosmetic outcome [ Time Frame: 12 or 16 weeks after treatment ]
  3. Sustained clearance rate over 3 year follow-up [ Time Frame: 3 years after treatment ]
  4. Tolerability & QoL [ Time Frame: 12 or 16 weeks after treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

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
Antineoplastic Agents
Interferon Inducers