1-Year Follow up to the 1473-IMIQ Study

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00114023
First received: June 13, 2005
Last updated: February 16, 2007
Last verified: October 2006
  Purpose

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
Keratosis
Drug: Imiquimod 5% cream
Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114023

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
  More Information

No publications provided

ClinicalTrials.gov 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:
AK
Imiquimod 5% cream
3M Pharmaceuticals
Aldara
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on August 28, 2014