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Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage


Phase 4
18 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information

Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage


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.


Inclusion Criteria:



1. Are willing and able to give informed consent;

2. Are at least 18 years of age;

3. Are willing to comply with all study requirements, evaluations, and procedures

4. 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

5. Are free of any significant physical abnormalities or previous scarring in the
potential application site area that may cause difficulty with examinations.

6. 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:

1. 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.

2. Have any dermatological disease in the treatment or surrounding area that may be
exacerbated by treatment with imiquimod or cause difficulty with examination.

3. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.

4. Are pregnant at the screening or treatment initiation visit.

5. Have known allergies to any excipient in the study cream

6. 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

histologic clearance of basal cell carcinoma

Principal Investigator

Phillip M Williford, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

BG04-484

NCT ID:

NCT00314756

Start Date:

March 2005

Completion Date:

November 2005

Related Keywords:

  • Basal Cell Carcinoma
  • imiquimod cream
  • nodular basal cell carcinoma
  • curettage
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location

Wake Forest University Medical CenterWinston-Salem, North Carolina  27157