NCT00189254

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2005

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

February 7, 2022

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

September 12, 2005

Last Update Submit

February 4, 2022

Conditions

Actinic Keratoses

Keywords

1 year follow up

Outcome Measures

Primary Outcomes (3)

  • 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).

    one year after completion of study 1487-Imiq

  • Safety

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

    one year after completion of study 1487-Imiq

  • Adverse Events

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

    one year after completion of study 1487-Imiq

Study Arms (1)

Imiquimod 5% cream

No investigational treatments were given during this study.

Drug: Imiquimod

Interventions

ImiquimodDRUG

No defined treatments were given during this study.

Imiquimod 5% cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Study Coordinator

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

April 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

February 7, 2022

Record last verified: 2015-04