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

A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara...

Date First Received: December 21, 2007

Last Updated: April 29, 2009

Verified by: The University of Texas Health Science Center, Houston, April 2009

Clinical Trial Phase: Phase 4 | Start Date: December 2007

Overall Status: Active, not recruiting

Estimated Enrollment: 49

Brief Summary

Official Title: “Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp”

Condition Keyword(s):

A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.

Study Type: Interventional

Study Design: Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

  • Biological: Imiquimod and Interferon alpha
    • Imiquimod first two weeks and last two weeks. Interferon middle five weeks.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Treated

Outcome Measures for this Clinical Trial

Primary Measures

  • resolution of basal cell carcinoma
    • Time Frame: 2 years
      Safety Issue?: No

Secondary Measures

  • resolution of basal cell carcinoma at a lower cost and less inflammation.
    • Time Frame: 2 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: The University of Texas Health Science Center, Houston

Overall Clinical Trial Officials and Contacts

Stephen B Tucker, M.D. Principal Investigator University of Texas Health Science Center of Houston Dermatology Clinic  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00581425

Study ID Number: HSC-MS-06-0478

ClinicalTrials.gov Identifier: NCT00581425

Health Authority: United States: Institutional Review Board

Clinical Trials Authorship and Review

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