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CompletedNCT00189254Updated Feb 7, 2022

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

An observational study in Actinic Keratoses, sponsored by MEDA Pharma GmbH & Co. KG. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-07.

Sponsored by MEDA Pharma GmbH & Co. KG (part of Viatris Inc.) · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
72
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Actinic Keratoses

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Keywords

  • 1 year follow up
03

In context

Keratosis, Actinic

369 studies on the registry are indexed under Keratosis, Actinic; 30 are open to participants now.

This study's enrollment of 72 is below the median of 179 across 37 observational studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

MEDA Pharma GmbH & Co. KG is the lead sponsor of 24 studies on the registry; none are open to participants now.

First submitted before MEDA Pharma GmbH & Co. KG became part of Viatris Inc..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • used any treatments in the previous treatment area within 24 hours prior to the follow-up visit
05

Study design

Time perspective
Prospective
Enrollment
72 participants

Groups and cohorts

  • Imiquimod 5% cream

    No investigational treatments were given during this study.

    Drug: Imiquimod

Interventions

  • No defined treatments were given during this study.

06

What researchers measure

Primary outcomes

  1. Efficacy

    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).

    Time frame: one year after completion of study 1487-Imiq

  2. Safety

    Safety was evaluated by assessing the area of previous treatment for LSRs and skin quality

    Time frame: one year after completion of study 1487-Imiq

  3. Adverse Events

    AEs considered by investigator to be possibly or probably related to the 1487-Imiq study medication were documented and recorded.

    Time frame: one year after completion of study 1487-Imiq

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00189254
Responsible party
Sponsor
First posted
Sep 19, 2005
Start date
Apr 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Feb 7, 2022

Study contacts

Study Coordinator
study chair · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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