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

Sponsor
Hoffmann-La Roche
Study ID
NCT00718315
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib [Tarceva] — DRUG
    150mg po daily
  • fusidic acid [Verutex] — DRUG
    topical, daily for 30 days.
  • erythromycin [Eritex] — DRUG
    topical, daily for 30 days.
  • Fisiogel — DRUG
    topical, daily for 30 days

Study Details

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.

Key Dates

First listed
Jul 18, 2008
Start date
Apr 30, 2009
Status verified
Jan 2015
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
201 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2
  • Experimental: 3

Primary Outcome Measure

Percentage of Participants Who Develop Skin Rash [ Time Frame: 30 Days ]

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