Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

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...

Date First Received: June 30, 2005

Last Updated: January 4, 2008

Verified by: Graceway Pharmaceuticals, LLC, January 2008

Clinical Trial Phase: Phase 4 | Start Date: June 2005

Overall Status: Completed

Estimated Enrollment: 500

Brief Summary

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”

Condition Keyword(s):

Intervention(s):

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2007

Intervention(s) in this Clinical Trial

  • Drug: imiquimod cream

Outcome Measures for this Clinical Trial

Primary Measures

  • 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 Measures

  • To evaluate the efficacy of treatment with imiquimod in this population of subjects with actinic keratosis

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Graceway Pharmaceuticals, LLC

Additional Information

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00116649

Study ID Number: 1520-IMIQ

ClinicalTrials.gov Identifier: NCT00116649

Health Authority: United States: Food and Drug Administration

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