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Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage

Primary Purpose

Basal Cell Carcinoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
imiquimod
Sponsored by
Wake Forest University
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Are willing and able to give informed consent; Are at least 18 years of age; Are willing to comply with all study requirements, evaluations, and procedures Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria: a primary lesion (not recurrent, not previously treated or biopsied) non-infected size between 0.25 and 1.5 cm2 located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face clinically consistent with nodular BCC histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern suitable for treatment with surgical excision easily identifiable and treatable by subject or reliable subject representative Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations. Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits. Exclusion Criteria: Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study. Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline. Are pregnant at the screening or treatment initiation visit. Have known allergies to any excipient in the study cream Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.

Sites / Locations

  • Wake Forest University Medical Center

Outcomes

Primary Outcome Measures

histologic clearance of basal cell carcinoma

Secondary Outcome Measures

Full Information

First Posted
April 12, 2006
Last Updated
August 21, 2023
Sponsor
Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT00314756
Brief Title
Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage
Official Title
Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

5. Study Description

Brief Summary
To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage
Detailed Description
The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular BCC lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. The secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
imiquimod
Primary Outcome Measure Information:
Title
histologic clearance of basal cell carcinoma

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are willing and able to give informed consent; Are at least 18 years of age; Are willing to comply with all study requirements, evaluations, and procedures Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria: a primary lesion (not recurrent, not previously treated or biopsied) non-infected size between 0.25 and 1.5 cm2 located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face clinically consistent with nodular BCC histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern suitable for treatment with surgical excision easily identifiable and treatable by subject or reliable subject representative Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations. Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits. Exclusion Criteria: Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study. Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline. Are pregnant at the screening or treatment initiation visit. Have known allergies to any excipient in the study cream Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip M Williford, MD
Organizational Affiliation
Wake Forest University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage

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