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
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Purpose
A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.
| Condition | Intervention | Phase |
|---|---|---|
|
Basal Cell Carcinoma |
Biological: Imiquimod and Interferon alpha |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp |
Resource links provided by NLM:
Further study details as provided by The University of Texas Health Science Center, Houston:
Primary Outcome Measures:
- resolution of basal cell carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- resolution of basal cell carcinoma at a lower cost and less inflammation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 49 |
| Study Start Date: | December 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treated |
Biological: Imiquimod and Interferon alpha
Imiquimod first two weeks and last two weeks. Interferon middle five weeks.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Nodular or superficial basal cell carcinoma on the skin excluding scalp or face
Exclusion Criteria:
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581425
Locations
| United States, Texas | |
| University of Texas Health Science Center of Houston Dermatology Clinic | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
| Principal Investigator: | Stephen B Tucker, M.D. | University of Texas Health Science Center of Houston Dermatology Clinic |
More Information
No publications provided
| Responsible Party: | Stephen Tucker, Visiting Professor - Dermatology, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00581425 History of Changes |
| Other Study ID Numbers: | HSC-MS-06-0478, OSP-24412 |
| Study First Received: | December 21, 2007 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center, Houston:
|
BCC Basal Cell Carcinoma Intron-A Aldara Basal Cell Carcinoma excluding scalp and face |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Reaferon Imiquimod Antiviral Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Adjuvants, Immunologic Alcohol Deterrents Central Nervous System Agents Interferon Inducers |
ClinicalTrials.gov processed this record on June 17, 2013