Intron-A/Aldara Combination Therapy for Basal Cell Carcin... | NCT00581425

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

NCT00581425

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Jan 25, 2013Estimated

Enrollment

49Actual

Phase

Phase 4

Conditions

Basal Cell Carcinoma

Interventions

Imiquimod and Interferon alpha

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OSP-24412

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 26, 2007

First Posted Date

Dec 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2013

Last Update Posted Date

Jan 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephen Tucker, Visiting Professor - Dermatology, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treated	Experimental		Biological: Imiquimod and Interferon alpha

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imiquimod and Interferon alpha	Biological	Imiquimod first two weeks and last two weeks. Interferon middle five weeks.	Treated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
resolution of basal cell carcinoma		2 years

Secondary Outcomes

Measure	Description	Time Frame
resolution of basal cell carcinoma at a lower cost and less inflammation.		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Health Science Center of Houston Dermatology Clinic		Houston	Texas	77030	United States

Type	Date	Date Unknown
Release	Jun 26, 2013
Reset	Sep 5, 2013

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 26, 2013			Sep 5, 2013

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell
D019066	Facies

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077271	Imiquimod
D016898	Interferon-alpha

Ancestor Terms

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided