A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
NCT ID: NCT00642473
Last Updated: 2016-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2008-02-29
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prevention (Erlotinib + Metronidazole Actavis)
Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated at the same day as the start of erlotinib. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Erlotinib
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Metronidazole Actavis
Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
Non-active Moisturizing Cream
Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Treatment (Erlotinib + Metronidazole Actavis)
Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated when participants develop rash. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
Erlotinib
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Metronidazole Actavis
Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
Non-active Moisturizing Cream
Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Interventions
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Erlotinib
Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks.
Metronidazole Actavis
Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks.
Non-active Moisturizing Cream
Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* eligible to start treatment with erlotinib
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Gothenburg, , Sweden
Lund, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Vaxjo, , Sweden
Countries
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Other Identifiers
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2007-002895-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML21308
Identifier Type: -
Identifier Source: org_study_id
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