NCT00189241

Brief Summary

The purpose of this study is to evaluate the long-term sustained clearance rate of superficial basal cell carcinoma during a 5 year period following treatment with imiquimod

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_3

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

February 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 7, 2022

Status Verified

August 1, 2010

Enrollment Period

6 years

First QC Date

September 12, 2005

Last Update Submit

February 4, 2022

Conditions

Basal Cell Carcinoma

Keywords

AldaraSuperficial Basal Cell CarcinomaLong-Term Study

Outcome Measures

Primary Outcomes (1)

  • To evaluate the long-term sustained clearance rate, defined as the proportion of subjects who are clinically clear of sBCC at the treated sBCC target tumour site at the 12 week posttreatment visit and remain clear during the 5 year follow-up period.

Secondary Outcomes (1)

  • To evaluate the safety and cosmetic outcome of once daily 5 days per week dosing for 6 weeks with imiquimod 5% cream in the treatment of sBCC

Interventions

imiquimodDRUG

Eligibility Criteria

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

You may qualify if:

  • Have one superficial BCC - primary tumour
  • Minimum tumour area of 0.5cm2, maximum diameter of 2.0cm.
  • If female and of child bearing potential, negative pregnancy test and willing to use medically acceptable method of contraception.

You may not qualify if:

  • Evidence of clinically significant, unstable medical conditions.
  • Evidence of Gorlin syndrome, metastatic tumour or tumour with high probability of metastatic spread, have or have had within last 5 years other malignant cancers of the skin at target tumour site.
  • Have received defined treatments in tumour site or surrounding area.
  • Any dermatological disease in the target tumour site or surrounding area.
  • Have had a systemic bacterial or viral infection within 2 weeks prior to study initiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univertätsklinik für Dermatologie und Venerologie

Magedeburg, Germany

Location

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

September 12, 2005

First Posted

September 19, 2005

Study Start

February 1, 2001

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

February 7, 2022

Record last verified: 2010-08

Locations

DE(1)