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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | April 29, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
resolution of basal cell carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00581425 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
resolution of basal cell carcinoma at a lower cost and less inflammation. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
resolution of basal cell carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC) | ||||
| Official Title ICMJE | Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp | ||||
| Brief Summary | A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Basal Cell Carcinoma | ||||
| Intervention ICMJE | Biological: Imiquimod and Interferon alpha | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 49 | ||||
| Estimated Completion Date | May 2011 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00581425 | ||||
| Responsible Party | Stephen B. Tucker, M.D., The University of Texas Health Science Center, Houston | ||||
| Study ID Numbers ICMJE | HSC-MS-06-0478, OSP-24412 | ||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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