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A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base

NCT ID: NCT00463359

Last Updated: 2007-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas on the face removed with curettage and electrodessication (cautery) followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with curettage and electrodessication alone.

Detailed Description

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Basal Cell Carcinomas (BCC) are the commonest form of skin cancer in the white population. The face is where they most frequently occur and the nodular BCCs are the commonest type. Curettage and cautery/electrodessication (C\&C) has been an established way of management of nodular BCCs for years, being a simple surgical procedure readily performed in outpatient clinics with good aesthetic results and high cure rates. The purpose of this study is to determine recurrence rates of nodular BCCs on the face removed with C\&C followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with C\&C alone. Imiquimod is an immune response modifier with anti-tumour effects already licensed for the treatment of superficial BCCs in the UK.

Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Imiquimod cream

Intervention Type DRUG

curettage and cautery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Well-defined primary, not previously treated nodulo-cystic BCC
* Size of the lesions: ≤ 1cm diameter
* Facial lesions
* Patient compliance competent
* Patient physically able to apply the treatment (cream)

Exclusion Criteria

* Recurrent lesions
* Superficial, morphoeic or pigmented BCC
* Lesions close to vital structures; i.e. where C\&C is not considered a standard treatment (eyelids, inner canthus, free borders)
* Lesions within 1 cm of the eyelids, nose, lips and hairline
* Immunosuppressed patients
* Women in childbearing age, pregnancy and breast-feeding
* Ages \<50 or \>90
* Patients compliance incompetent
* Patients physically incapable to apply the treatment (cream)
* Patients with Gorlin Syndrome (nevoid Basal Cell Carcinoma syndrome)
Minimum Eligible Age

49 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

Glasgow Western Infirmary

OTHER

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role lead

Principal Investigators

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Lorna MacKintosh, Specialist Registrar

Role: PRINCIPAL_INVESTIGATOR

Western Infirmary

Areti Makrygeorgou, Staff Grade Dr

Role: STUDY_CHAIR

Western Infirmary

Locations

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Dermatology Department, Western Infirmary

Glasgow, Lanarkshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Robert Herd, Consultant Dermatologist

Role: CONTACT

[email protected]
+441412111000 ext. 6259

Facility Contacts

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Robert Herd, Consultant Dermatologist

Role: primary

[email protected]
+441412111000 ext. 6259

Areti Makrygeorgou, Staff Grade Dr

Role: backup

[email protected]
+441412111000 ext. 2903

Other Identifiers

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EudraCT No: 2007-001961-14

Identifier Type: -

Identifier Source: secondary_id

WN07DE002

Identifier Type: -

Identifier Source: org_study_id