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NCT Number: NCT00189280

Aldara for the Treatment of Large and/or Multiple sBCC

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.

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Key information

Conditions

Carcinoma, Basal Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de DermatologieHôpital Dupuytren

Limoges, 87042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imiquimod

Drug

cream 5%, 5 days out of seven, for 6 weeks

Primary outcomes

  1. Clinical clearance of sBCC

    Time frame: 12 or 16 weeks after treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

MEDA Pharma GmbH & Co. KG

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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