Not Signed In -
Penciclovir Cream |
Denavir |
Clinical Trial: Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
This study is not yet open for patient recruitment.
|
Purpose
Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.
| Condition | Intervention | Phase |
|---|---|---|
| Keratosis | Drug: imiquimod cream | Phase IV |
MedlinePlus related topics: Skin Diseases
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater than 25 cm2 with Actinic Keratosis
Further Study Details:
Primary Outcomes: To evaluate the safety of 1, 2, or 3 16-week cycles of imiquimod for the treatment of actinic keratosis lesions totaling greater than 25 square centimeters
Secondary Outcomes: To evaluate the efficacy of treatment with imiquimod in this population of subjects with actinic keratosis
Expected Total Enrollment: 500
Secondary Outcomes: To evaluate the efficacy of treatment with imiquimod in this population of subjects with actinic keratosis
Expected Total Enrollment: 500
Study start: June 2005; Expected completion: December 2007
Last follow-up: May 2007; Data entry closure: July 2007
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Are at least 18 years of age.
- Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.
Exclusion Criteria:
- Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
- Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00116649
California
Skin Surgery Medical Group, Inc., San Diego, California, 92117, United States
Alisa Schweikl, RN 858-292-8641
Kenneth Gross, MD, Principal Investigator
Kenneth Gross, MD, Principal Investigator
More Information
Study ID Numbers: 1520-IMIQ
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 30, 2005
ClinicalTrials.gov Identifier: NCT00116649
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 30, 2005
ClinicalTrials.gov Identifier: NCT00116649
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
Resources
- Denavir (Drug Digest)
- Penciclovir Cream (Drug Digest)
email this page
print this page
bookmark this page
feedback on this page
