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Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)

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ClinicalTrials.gov Identifier: NCT00581425
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : January 25, 2013
Sponsor:
Information provided by (Responsible Party):
Stephen Tucker, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Biological: Imiquimod and Interferon alpha Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp
Study Start Date : December 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treated Biological: Imiquimod and Interferon alpha
Imiquimod first two weeks and last two weeks. Interferon middle five weeks.




Primary Outcome Measures :
  1. resolution of basal cell carcinoma [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. resolution of basal cell carcinoma at a lower cost and less inflammation. [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nodular or superficial basal cell carcinoma on the skin excluding scalp or face

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

Keywords provided by Stephen Tucker, 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
Imiquimod
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Interferon Inducers