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An Open-Label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 5 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information

An Open-Label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 5 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma


Inclusion Criteria:



- Have one superficial BCC - primary tumour

- Minimum tumour area of 0.5cm2, maximum diameter of 2.0cm.

- If female and of child bearing potential, negative pregnancy test and willing to use
medically acceptable method of contraception.

Exclusion Criteria:

- Evidence of clinically significant, unstable medical conditions.

- Evidence of Gorlin syndrome, metastatic tumour or tumour with high probability of
metastatic spread, have or have had within last 5 years other malignant cancers of
the skin at target tumour site.

- Have received defined treatments in tumour site or surrounding area.

- Any dermatological disease in the target tumour site or surrounding area.

- Have had a systemic bacterial or viral infection within 2 weeks prior to study
initiation.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the long-term sustained clearance rate, defined as the proportion of subjects who are clinically clear of sBCC at the treated sBCC target tumour site at the 12 week posttreatment visit and remain clear during the 5 year follow-up period.

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

1412-IMIQ

NCT ID:

NCT00189241

Start Date:

February 2001

Completion Date:

February 2007

Related Keywords:

  • Basal Cell Carcinoma
  • Aldara
  • Superficial Basal Cell Carcinoma
  • Long-Term Study
  • Carcinoma
  • Carcinoma, Basal Cell

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