NCT00189306

Brief Summary

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_3

Geographic Reach
2 countries

18 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

March 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 26, 2008

Completed
Last Updated

August 10, 2010

Status Verified

August 1, 2010

Enrollment Period

6.1 years

First QC Date

September 13, 2005

Results QC Date

October 30, 2008

Last Update Submit

August 5, 2010

Conditions

Superficial Basal Cell Carcinoma

Keywords

Superficial Basal Cell CarcinomaAldara

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)

    Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.

    5 years

Secondary Outcomes (1)

  • Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks

    12 week posttreatment visit

Study Arms (1)

Aldara

EXPERIMENTAL

Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks

Drug: Imiquimod 5% cream

Interventions

Imiquimod 5% creamDRUG

Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks

Also known as: Aldara (imiquimod) 5% cream - 250 mg / packet
Aldara

Eligibility Criteria

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

You may qualify if:

  • Have at least 1 previously untreated superficial basal cell carcinoma tumor
  • Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm

You may not qualify if:

  • Evidence of clinically significant, unstable medical conditions
  • Cannot have recent use of topical steroids or retinoids in the treatment area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Medical Centre, Concord Hospital

Concord, New South Wales, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, Australia

Location

Skin Centre

Benowa, Queensland, Australia

Location

South East Dermatology Centre

Carina Heights, Queensland, Australia

Location

105 Fulham Road

Gulliver, Queensland, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

Flinders Medical Center

Bedford Park, South Australia, Australia

Location

Queen Elizabeth Hospital

Woodville, South Australia, Australia

Location

Western Hospital

Footscray, Victoria, Australia

Location

Austin & Repartriation Hospital

Heidelburg, Victoria, Australia

Location

Freemantle Dermatology

Fremantle, Western Australia, Australia

Location

158 South Terrace

Perth, Western Australia, Australia

Location

Subiaco Clinic

Subiaco, Western Australia, Australia

Location

103A Mountain Road

Epsom, Auckland, New Zealand

Location

Birthcare Building

Parnell, Auckland, New Zealand

Location

Colombo Mansions

Christchurch, New Zealand

Location

Dermatology Practice

Christchurch, New Zealand

Location

Skin Institute Limited

Takapuna, New Zealand

Location

Related Publications (2)

  • Quirk C, Gebauer K, Owens M, Stampone P. Two-year interim results from a 5-year study evaluating clinical recurrence of superficial basal cell carcinoma after treatment with imiquimod 5% cream daily for 6 weeks. Australas J Dermatol. 2006 Nov;47(4):258-65. doi: 10.1111/j.1440-0960.2006.00313.x.

    PMID: 17034468RESULT

  • Quirk C, Gebauer K, De'Ambrosis B, Slade HB, Meng TC. Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study. Cutis. 2010 Jun;85(6):318-24.

    PMID: 20666194RESULT

MeSH Terms

Interventions

Imiquimod

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Medical Director
Organization
Graceway Pharmaceuticals
jim.lee@gracewaypharma.com
267-984-0400

Study Officials

  • Jim Lee, Dr.

    Graceway Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 13, 2005

First Posted

September 19, 2005

Study Start

March 1, 2001

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 10, 2010

Results First Posted

November 26, 2008

Record last verified: 2010-08

Locations

NZ(5)AU(13)