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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.
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG Identifier:
First received: September 12, 2005
Last updated: November 28, 2016
Last verified: April 2015
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 ]
    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 ]
    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 ]
    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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
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Please refer to this study by its identifier: NCT00189254

Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
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 Identifier: NCT00189254     History of Changes
Other Study ID Numbers: 1524-IMIQ
Study First Received: September 12, 2005
Last Updated: November 28, 2016

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

Additional relevant MeSH terms:
Keratosis, Actinic
Disease Attributes
Pathologic Processes
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers processed this record on May 25, 2017