Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

NCT ID: NCT00189306

Last Updated: 2010-08-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

Conditions

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Superficial Basal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aldara

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

Group Type EXPERIMENTAL

Imiquimod 5% cream

Intervention Type DRUG

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

Interventions

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Imiquimod 5% cream

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

Intervention Type DRUG

Other Intervention Names

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Aldara (imiquimod) 5% cream - 250 mg / packet

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Graceway Pharmaceuticals, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Graceway Pharmaceuticals

Principal Investigators

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Jim Lee, Dr.

Role: STUDY_DIRECTOR

Graceway Pharmaceuticals

Locations

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Medical Centre, Concord Hospital

Concord, New South Wales, Australia

Site Status

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status

Skin Centre

Benowa, Queensland, Australia

Site Status

South East Dermatology Centre

Carina Heights, Queensland, Australia

Site Status

105 Fulham Road

Gulliver, Queensland, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Flinders Medical Center

Bedford Park, South Australia, Australia

Site Status

Queen Elizabeth Hospital

Woodville, South Australia, Australia

Site Status

Western Hospital

Footscray, Victoria, Australia

Site Status

Austin & Repartriation Hospital

Heidelburg, Victoria, Australia

Site Status

Freemantle Dermatology

Fremantle, Western Australia, Australia

Site Status

158 South Terrace

Perth, Western Australia, Australia

Site Status

Subiaco Clinic

Subiaco, Western Australia, Australia

Site Status

103A Mountain Road

Epsom, Auckland, New Zealand

Site Status

Birthcare Building

Parnell, Auckland, New Zealand

Site Status

Colombo Mansions

Christchurch, , New Zealand

Site Status

Dermatology Practice

Christchurch, , New Zealand

Site Status

Skin Institute Limited

Takapuna, , New Zealand

Site Status

Countries

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Australia New Zealand

References

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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.

Reference Type RESULT
PMID: 17034468 (View on PubMed)

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.

Reference Type RESULT
PMID: 20666194 (View on PubMed)

Other Identifiers

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1413-IMIQ

Identifier Type: -

Identifier Source: org_study_id

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