KeratosisNCT00114023
1-Year Follow up to the 1473-IMIQ Study
An observational study of Keratosis, run by Graceway Pharmaceuticals, LLC at 1 site in United States.
Trial summary
This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratosis
- What is being tested?
- Imiquimod 5% cream
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject had to participate in the 1473-IMIQ Study AND have had 100% clearance of AK lesions
Who cannot join
- Did not use any topical preparations in the previous treatment area within 24-hours of the scheduled visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Follow-up Study to Evaluate Actinic Keratosis Recurrence Rates One Year After Completion of the 1473-IMIQ Study
This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK.
- Conditions
- Keratosis
- Being tested
- Imiquimod 5% cream
- Keywords
- AK, Imiquimod 5% cream, 3M Pharmaceuticals, Aldara, Actinic Keratosis
- Medical subject headings
- Keratosis, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod 5% creamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratosisStudies 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
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114023
- Sponsor's protocol ID
- 1518-IMIQ
- Status last verified
- Oct 2006
- First submitted
- 13 Jun 2005
- Last updated
- 19 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2007. 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 1473-IMIQ Study
- ClinicalTrials.gov ID
- NCT00114023
- Acronym / sponsor ID
- 1518-IMIQ
- Conditions
- Keratosis
- Keywords
- AK, Imiquimod 5% cream, 3M Pharmaceuticals, Aldara, Actinic Keratosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- Graceway Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- First posted
- 14 Jun 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.
This is a 1-year follow-up study to evaluate the long-term effects in subjects who completely cleared their actinic keratosis (AK) lesions in the 1473-IMIQ study. The 1473-IMIQ study evaluated the safety and effectiveness of imiquimod 5% cream compared to a placebo cream for the treatment of AK.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject had to participate in the 1473-IMIQ Study AND have had 100% clearance of AK lesions
Key exclusion criteria (1 listed)
- Did not use any topical preparations in the previous treatment area within 24-hours of the scheduled 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 |
|---|---|---|
| Imiquimod 5% cream | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Feb 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratosis, run by Graceway Pharmaceuticals, LLC at 1 site in United States.
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 19 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 19 Feb 2007.