CompletedPhase 3

A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.

Brazil201 participantsStarted 2009-04

Plain-language summary

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * adult patients, \>=18 years of age; * locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV); * eligible to start treatment with Tarceva, or receiving Tarceva for \<=5 days. Exclusion Criteria: * presence of skin rash or other signs of skin toxicity; * treatment with any systemic or intranasal antibiotic within 7 days before randomization; * treatment with other topical formulation within 14 days before randomization; * other anticancer therapy in addition to Tarceva.

What they're measuring

Percentage of Participants Who Develop Skin Rash

Timeframe: 30 Days

Percentage of Participants With Skin Rash Stratified by Severity Grade

Timeframe: 30 Days

Trial details

NCT IDNCT00718315

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-06

Results submitted2015-01-09

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer trials