NCT00129519

Brief Summary

The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant therapy, will have an improved cure rate over the ED/C historical norm of approximately 70% at 1-year posttreatment follow-up. A secondary objective is to assess cosmetic outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

3 active sites

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

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

July 16, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

August 11, 2005

Last Update Submit

July 14, 2010

Conditions

Basal Cell Carcinoma

Keywords

BCC curettage

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with recurrence

    Primary variable was the proportion of subjects with recurrence/persistence (R/P)of BCC at 1 year posttreatment

    1 year posttreatment

Secondary Outcomes (1)

  • Cosmetic outcome of the target lesion

    1 year posttreatment

Study Arms (1)

Imiquimod cream

ACTIVE COMPARATOR

Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks

Drug: Imiquimod 5% cream

Interventions

Imiquimod 5% creamDRUG

Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks

Imiquimod cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Basal cell carcinoma

You may not qualify if:

  • Psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Grass Valley, California, 95945, United States

Location

Unknown Facility

Loma Linda, California, 92354, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Related Publications (1)

  • Rigel DS, Torres AM, Ely H. Imiquimod 5% cream following curettage without electrodesiccation for basal cell carcinoma: preliminary report. J Drugs Dermatol. 2008 Jan;7(1 Suppl 1):s15-6.

    PMID: 18277458BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 12, 2005

Study Start

January 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

July 16, 2010

Record last verified: 2010-07

Locations

US(3)