NCT00463359

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

April 19, 2007

Last Update Submit

April 19, 2007

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinomacurettageImiquimodtreatment

Outcome Measures

Primary Outcomes (1)

  • Basal Cell Carcinoma recurrence rates in 3 years

Interventions

Imiquimod creamDRUG
curettage and cauteryPROCEDURE

Eligibility Criteria

Age49 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Department, Western Infirmary

Glasgow, Lanarkshire, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

CurettageCautery

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeTherapeuticsAblation Techniques

Study Officials

  • Lorna MacKintosh, Specialist Registrar

    Western Infirmary

    PRINCIPAL INVESTIGATOR

  • Areti Makrygeorgou, Staff Grade Dr

    Western Infirmary

    STUDY CHAIR

Central Study Contacts

Robert Herd, Consultant Dermatologist

CONTACT

+441412111000robert.herd@northglasgow.scot.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 20, 2007

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

GB(1)