Actinic KeratosesNCT00189254
A Study to Follow up Recurrence Rates of Actinic Keratoses One Year After Completion of Study 1487-IMIQ
An observational study of Actinic Keratoses, run by MEDA Pharma GmbH & Co. KG.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Imiquimod
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 100% clearance of Actinic Keratosis (AK) lesions in the 1487 IMIQ study
Who cannot join
- used any treatments in the previous treatment area within 24 hours prior to the follow-up visit
About this study
Official title: A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1487-IMIQ Study
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.
- Conditions
- Actinic Keratoses
- Being tested
- Imiquimod
- Keywords
- 1 year follow up
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
No defined treatments were given during this study.
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod 5% cream | No investigational treatments were given during this study. Receives: Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year after completion of study 1487-Imiq
Safety
Safety was evaluated by assessing the area of previous treatment for LSRs and skin quality
Measured: 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.
Measured: one year after completion of study 1487-Imiq
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Coordinator, Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189254
- Sponsor's protocol ID
- 1524-IMIQ
- Status last verified
- Apr 2015
- First submitted
- 12 Sep 2005
- Last updated
- 7 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1487-IMIQ Study
- ClinicalTrials.gov ID
- NCT00189254
- Acronym / sponsor ID
- 1524-IMIQ
- Conditions
- Actinic Keratoses
- Keywords
- 1 year follow up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imiquimod 5% cream | – | Drug: ImiquimodNo investigational treatments were given during this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 100% clearance of Actinic Keratosis (AK) lesions in the 1487 IMIQ study
Key exclusion criteria (1 listed)
- used any treatments in the previous treatment area within 24 hours prior to the follow-up visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImiquimodNo defined treatments were given during this study. | Drug | Imiquimod 5% cream |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Coordinator study chair
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratoses, run by MEDA Pharma GmbH & Co. KG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: one year after completion of study 1487-Imiq). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.