CompletedPhase 3

A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma

Germany160 participantsStarted 2001-02

Plain-language summary

The purpose of this study is to evaluate the long-term sustained clearance rate of superficial basal cell carcinoma during a 5 year period following treatment with imiquimod

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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.

Trial details

NCT IDNCT00189241

SponsorMEDA Pharma GmbH & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02

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