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A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ

This study has been completed.
Sponsor:
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00189254
First received: September 12, 2005
Last updated: February 20, 2007
Last verified: August 2006
  Purpose

The purpose of the study is to obtain recurrence rates and long-term safety data for patients who had been treating actinic keratoses on the face and scalp with 5 % Imiquimod Cream in a previous study.


Condition Phase
Actinic Keratoses
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 1487-IMIQ Study

Resource links provided by NLM:


Further study details as provided by MEDA Pharma GmbH & Co. KG:

Estimated Enrollment: 73
Study Start Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 100% clearance of Actinic Keratosis (AK) lesions in the 1487 IMIQ study

Exclusion Criteria:

  • used any treatments in the previous treatment area within 24 hours prior to the follow-up 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: NCT00189254

Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Investigators
Study Chair: Study Coordinator Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189254     History of Changes
Other Study ID Numbers: 1524-IMIQ
Study First Received: September 12, 2005
Last Updated: February 20, 2007
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines

Keywords provided by MEDA Pharma GmbH & Co. KG:
1 year follow up

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Recurrence
Disease Attributes
Neoplasms
Pathologic Processes
Precancerous Conditions
Skin Diseases

ClinicalTrials.gov processed this record on November 23, 2014