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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
History of Changes
  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
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 1487-IMIQ Study

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
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
Skin Diseases
 Precancerous Conditions
Neoplasms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013