Basal Cell CarcinomaNCT00463359
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
A study testing Imiquimod cream and curettage and cautery in people with Basal Cell Carcinoma, run by University of Glasgow at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 49 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Imiquimod cream and curettage and cautery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Ages <50 or >90
- Patients compliance incompetent
- Patients physically incapable to apply the treatment (cream)
- Patients with Gorlin Syndrome (nevoid Basal Cell Carcinoma syndrome)
Trial locations and contacts
1 site in 1 country.
Robert Herd, Consultant Dermatologist contact
United Kingdom1 site
Dermatology Department, Western Infirmary
Glasgow, Lanarkshire, G11 6NT
Robert Herd, Consultant Dermatologist, +441412111000 ext. 6259, robert.herd@northglasgow.scot.nhs.uk
Areti Makrygeorgou, Staff Grade Dr, +441412111000 ext. 2903, amakrygeorgou@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Imiquimod cream, curettage and cautery
- Keywords
- basal cell carcinoma, curettage, Imiquimod, treatment
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod creamDrug
curettage and cauteryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal Cell Carcinoma recurrence rates in 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Glasgow Western Infirmary
- Investigators
- Lorna MacKintosh, Specialist Registrar, Principal investigator, Western InfirmaryAreti Makrygeorgou, Staff Grade Dr, Study chair, Western Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463359
- Sponsor's protocol ID
- WN07DE002
- Other IDs
- EudraCT No: 2007-001961-14
- Status last verified
- Apr 2007
- First submitted
- 19 Apr 2007
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00463359
- Acronym / sponsor ID
- WN07DE002
- Conditions
- Basal Cell Carcinoma
- Keywords
- basal cell carcinoma, curettage, Imiquimod, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, Glasgow Western Infirmary
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 49 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod cream | Drug | – |
| curettage and cautery | Procedure or surgery | – |
Primary outcome
Basal Cell Carcinoma recurrence rates in 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Herd, Consultant Dermatologist contact
Lorna MacKintosh, Specialist Registrar principal investigator
Western Infirmary
Areti Makrygeorgou, Staff Grade Dr study chair
Western Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imiquimod cream and curettage and cautery in people with Basal Cell Carcinoma, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Herd, Consultant Dermatologist (+441412111000 ext. 6259, robert.herd@northglasgow.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal Cell Carcinoma recurrence rates in 3 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.