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

Primary Purpose

Basal Cell Carcinoma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Imiquimod and Interferon alpha

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring BCC, Basal Cell Carcinoma, Intron-A, Aldara, Basal Cell Carcinoma excluding scalp and face

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy

Sites / Locations

University of Texas Health Science Center of Houston Dermatology Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated

Arm Description

Outcomes

Primary Outcome Measures

resolution of basal cell carcinoma

Secondary Outcome Measures

resolution of basal cell carcinoma at a lower cost and less inflammation.

Full Information

NCT ID

NCT00581425

First Posted

December 21, 2007

Last Updated

January 23, 2013

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT00581425

Brief Title

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

Official Title

Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basal Cell Carcinoma

Keywords

BCC, Basal Cell Carcinoma, Intron-A, Aldara, Basal Cell Carcinoma excluding scalp and face

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treated

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Imiquimod and Interferon alpha

Intervention Description

Imiquimod first two weeks and last two weeks. Interferon middle five weeks.

Primary Outcome Measure Information:

Title

resolution of basal cell carcinoma

Time Frame

2 years

Secondary Outcome Measure Information:

Title

resolution of basal cell carcinoma at a lower cost and less inflammation.

Time Frame

2 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Nodular or superficial basal cell carcinoma on the skin excluding scalp or face Exclusion Criteria: Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen B Tucker, M.D.

Organizational Affiliation

University of Texas Health Science Center of Houston Dermatology Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Science Center of Houston Dermatology Clinic

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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