Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)
This study has been completed.
Sponsor:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Stephen Tucker, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00581425
First received: December 21, 2007
Last updated: January 23, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | January 23, 2013 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | September 2011 (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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Basal Cell Carcinoma | ||||
| Intervention ICMJE | Biological: Imiquimod and Interferon alpha
Imiquimod first two weeks and last two weeks. Interferon middle five weeks. |
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| Study Arm (s) | Experimental: Treated
Intervention: Biological: Imiquimod and Interferon alpha |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 49 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| 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 Number ICMJE | NCT00581425 | ||||
| Other Study ID Numbers ICMJE | HSC-MS-06-0478, OSP-24412 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Stephen Tucker, The University of Texas Health Science Center, Houston | ||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||
| Verification Date | January 2013 | ||||
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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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