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A Phase II Trial Assessing Metronidazol Actavis 1% Topical Cream in the Prevention and Treatment of Erlotinib Associated Rash
This study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (\<) 3 months, and the target sample size is \<100 individuals.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Gothenburg, Sweden
Lund, Sweden
Malmo, Sweden
Stockholm, Sweden
Umeå, Sweden
Vaxjo, Sweden
Start Date
February 1, 2008
Primary Completion Date
March 1, 2009
Completion Date
March 1, 2009
Last Updated
May 23, 2016
34
ACTUAL participants
Erlotinib
DRUG
Metronidazole Actavis
DRUG
Non-active Moisturizing Cream
OTHER
Lead Sponsor
Hoffmann-La Roche
NCT06627647
NCT06417008
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06311721