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OpenTrials
Completed

NCT Number: NCT00189254

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

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imiquimod

Drug

No defined treatments were given during this study.

Primary outcomes

  1. 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).

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

MEDA Pharma GmbH & Co. KG

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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