NCT00581425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

3.8 years

First QC Date

December 21, 2007

Last Update Submit

January 23, 2013

Conditions

Basal Cell Carcinoma

Keywords

BCCBasal Cell CarcinomaIntron-AAldaraBasal Cell Carcinoma excluding scalp and face

Outcome Measures

Primary Outcomes (1)

  • resolution of basal cell carcinoma

    2 years

Secondary Outcomes (1)

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

    2 years

Study Arms (1)

Treated

EXPERIMENTAL
Biological: Imiquimod and Interferon alpha

Interventions

Imiquimod and Interferon alphaBIOLOGICAL

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

Treated

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center of Houston Dermatology Clinic

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal CellFacies

Interventions

ImiquimodInterferon-alpha

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Stephen B Tucker, M.D.

    University of Texas Health Science Center of Houston Dermatology Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Professor - Dermatology

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)