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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 (Responsible Party):
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00189254
First received: September 12, 2005
Last updated: November 28, 2016
Last verified: April 2015
  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 Intervention Phase
Actinic Keratoses
Drug: Imiquimod
Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
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:

Primary Outcome Measures:
  • Efficacy [ Time Frame: one year after completion of study 1487-Imiq ] [ Designated as safety issue: Yes ]
    Efficacy was evaluated by counting AK lesions in the previous treatment area. Subjects at the 1-year follow-up visit with recurrence of lesion(s).

  • Safety [ Time Frame: one year after completion of study 1487-Imiq ] [ Designated as safety issue: Yes ]
    Safety was evaluated by assessing the area of previous treatment for LSRs and skin quality

  • Adverse Events [ Time Frame: one year after completion of study 1487-Imiq ] [ Designated as safety issue: Yes ]
    AEs considered by investigator to be possibly or probably related to the 1487-Imiq study medication were documented and recorded.


Estimated Enrollment: 72
Study Start Date: April 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Imiquimod 5% cream
No investigational treatments were given during this study.
Drug: Imiquimod
No defined treatments were given during this study.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
At least 18 years old. Females of childbearing potential, with a negative urine pregnancy test, must have been willing to use a medically acceptable method of contraception during the treatment.
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

Responsible Party: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00189254     History of Changes
Other Study ID Numbers: 1524-IMIQ 
Study First Received: September 12, 2005
Last Updated: November 28, 2016
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:
Recurrence
Keratosis
Keratosis, Actinic
Disease Attributes
Pathologic Processes
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers

ClinicalTrials.gov processed this record on December 06, 2016