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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Imiquimod
Interferon-alpha
Interferons
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014