Aldara for the Treatment of Large and/or Multiple sBCC

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Meda Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Carcinoma, Basal Cell

Treatments

Drug: Imiquimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00189280
1475-IMIQ

Details and patient eligibility

About

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.

Enrollment

111 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

111 participants in 1 patient group

imiqimod 5% cream
Experimental group
Treatment:
Drug: Imiquimod

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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