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1-Year Follow up to the 1473-IMIQ Study

This study has been completed.
Information provided by:
Graceway Pharmaceuticals, LLC Identifier:
First received: June 13, 2005
Last updated: February 16, 2007
Last verified: October 2006
This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK.

Condition Intervention Phase
Drug: Imiquimod 5% cream
Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1473-IMIQ Study

Resource links provided by NLM:

Further study details as provided by Graceway Pharmaceuticals, LLC:

Estimated Enrollment: 84
Study Start Date: January 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject had to participate in the 1473-IMIQ Study AND have had 100% clearance of AK lesions

Exclusion Criteria:

  • Did not use any topical preparations in the previous treatment area within 24-hours of the scheduled visit.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00114023

United States, Arkansas
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
  More Information Identifier: NCT00114023     History of Changes
Other Study ID Numbers: 1518-IMIQ 
Study First Received: June 13, 2005
Last Updated: February 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
Imiquimod 5% cream
3M Pharmaceuticals
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers processed this record on October 21, 2016