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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

Primary Purpose

Basal Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Imiquimod cream
curettage and cautery
Sponsored by
University of Glasgow
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring basal cell carcinoma, curettage, Imiquimod, treatment

Eligibility Criteria

49 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Dermatology Department, Western Infirmary

Outcomes

Primary Outcome Measures

Basal Cell Carcinoma recurrence rates in 3 years

Secondary Outcome Measures

Full Information

First Posted
April 19, 2007
Last Updated
April 19, 2007
Sponsor
University of Glasgow
Collaborators
NHS Greater Glasgow and Clyde, Glasgow Western Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT00463359
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Glasgow
Collaborators
NHS Greater Glasgow and Clyde, Glasgow Western Infirmary

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
basal cell carcinoma, curettage, Imiquimod, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Imiquimod cream
Intervention Type
Procedure
Intervention Name(s)
curettage and cautery
Primary Outcome Measure Information:
Title
Basal Cell Carcinoma recurrence rates in 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Herd, Consultant Dermatologist
Phone
+441412111000
Ext
6259
Email
robert.herd@northglasgow.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna MacKintosh, Specialist Registrar
Organizational Affiliation
Western Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Areti Makrygeorgou, Staff Grade Dr
Organizational Affiliation
Western Infirmary
Official's Role
Study Chair
Facility Information:
Facility Name
Dermatology Department, Western Infirmary
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Herd, Consultant Dermatologist
Phone
+441412111000
Ext
6259
Email
robert.herd@northglasgow.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Areti Makrygeorgou, Staff Grade Dr
Phone
+441412111000
Ext
2903
Email
amakrygeorgou@hotmail.com
First Name & Middle Initial & Last Name & Degree
Areti Makrygeorgou, Staff Grade Dr
First Name & Middle Initial & Last Name & Degree
Robert Herd, Consultant Dermatologist
First Name & Middle Initial & Last Name & Degree
Lorna MacKintosh, Specialist Registrar

12. IPD Sharing Statement

Learn more about this trial

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

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