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Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%


Phase 2
18 Years
N/A
Not Enrolling
Male
Actinic Keratosis

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Trial Information

Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%


The primary objective of this study was to assess apoptosis by examining the gene expression
profiles of actinic keratosis (AK) lesions that were treated with imiquimod 5% cream or
vehicle cream once daily 3 times per week for 4 weeks. Secondary objectives were to assess
the utility of confocal microscopy (CM) to visually track cellular response to treatment
with study cream compared with clinical and histological evaluations, and to evaluate the
safety of treatment with imiquimod in subjects with AK on the balding scalp.


Inclusion Criteria:



- Have actinic keratoses on balding scalp

- Discontinuation of tanning bed use

- Discontinuation of moisturizers

- Avoidance of retinol products

Exclusion Criteria:

- Uncontrolled, clinically significant medical condition

- Dermatologic disease other than actinic keratosis in treatment area

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Gene expression profiling of treated lesions

Outcome Time Frame:

weeks 1, 2, and 4, and at 4 weeks post-treatment

Safety Issue:

No

Principal Investigator

TC Meng, MD

Investigator Role:

Study Director

Investigator Affiliation:

Graceway Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

1467-IMIQ

NCT ID:

NCT00335179

Start Date:

January 2003

Completion Date:

July 2003

Related Keywords:

  • Actinic Keratosis
  • Actinic keratosis
  • AK
  • imiquimod
  • confocal microscopy
  • gene microarray
  • Keratosis
  • Keratosis, Actinic

Name

Location

Loma Linda University Medical CenterLoma Linda, California  92354