Actinic KeratosesNCT00668733
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
An observational study of Actinic Keratoses, run by Graceway Pharmaceuticals, LLC.
Trial summary
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jul 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The study population consisted of subjects who have been treated with imiquimod or with placebo in one of the aformentioned studies and who demonstrated complete clearance of all clinically visible or palpable AK lesions in the selected treatment area at the end-of-study visit.
Who may be able to join
- Are willing and able to give informed consent;
- Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study
- Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.
Who cannot join
- None. All subjects who meet the inclusion criteria above may participate.
About this study
Official title: Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.
Read the detailed description
This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
The NCT numbers for the above mentioned studies are:
NCT00603798 - for Studies GW01-0703 and GW01-0705
NCT00605176 for Studies GW01-0702 and GW01-0704
- Conditions
- Actinic Keratoses
- Keywords
- Actinic keratoses, Dermatologic disease
- Medical subject headings
- Keratosis, Actinic, Skin Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrence of AK Lesions
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graceway Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sharon Levy, MD, Study director, Graceway Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668733
- Sponsor's protocol ID
- GW01-0803
- Status last verified
- Jul 2010
- First submitted
- 24 Apr 2008
- Last updated
- 20 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hanke CW, Swanson N, Bruce S, Berman B, Kulp J, Levy S. Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. J Drugs Dermatol. 2011 Feb;10(2):165-70.
PubMed 21283921
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705
- ClinicalTrials.gov ID
- NCT00668733
- Acronym / sponsor ID
- GW01-0803
- Conditions
- Actinic Keratoses
- Keywords
- Actinic keratoses, Dermatologic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Graceway Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 13 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.
Detailed description
This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
The NCT numbers for the above mentioned studies are:
NCT00603798 - for Studies GW01-0703 and GW01-0705
NCT00605176 for Studies GW01-0702 and GW01-0704
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of subjects who have been treated with imiquimod or with placebo in one of the aformentioned studies and who demonstrated complete clearance of all clinically visible or palpable AK lesions in the selected treatment area at the end-of-study visit.
Key inclusion criteria (3 listed)
- Are willing and able to give informed consent;
- Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study
- Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.
Key exclusion criteria (1 listed)
- None. All subjects who meet the inclusion criteria above may participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Recurrence of AK Lesions
Time frame: Up to one year
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21283921Hanke CW, Swanson N, Bruce S, Berman B, Kulp J, Levy S. Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. J Drugs Dermatol. 2011 Feb;10(2):165-70.
Related trials for Actinic Keratoses
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
Actinic Keratoses
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.
Sharon Levy, MD study director
Graceway Pharmaceuticals, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratoses, run by Graceway Pharmaceuticals, LLC.
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 3 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 20 Jul 2010. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Recurrence of AK Lesions (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00668733, which also lists 1 linked publication.
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 20 Jul 2010.