Actinic KeratosisPhase 4NCT00696488
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
A Phase 4 study testing Fluorouracil 0.5% in people with Actinic Keratosis, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Fluorouracil 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Oct 2008
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation.
Who cannot join
- Age less than 50.
- Known allergy or sensitivity to topical Carac® in the subject.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study.
- Subjects should not receive surgical or cryotherapy while participating in the study.
- Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27157
About this study
The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.
Read the detailed description
The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System
- Conditions
- Actinic Keratosis
- Being tested
- Fluorouracil 0.5%
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorouracil 0.5%Drug
Also called Carac
Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions
| Study group | Role | What they receive |
|---|---|---|
| Fluorouracil 0.5% | Experimental | each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions Receives: Drug: Fluorouracil 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.
Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionAug 2007
- Study completionOct 2008
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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696488
- Sponsor's protocol ID
- IRB00000156
- Other IDs
- 31358
- Status last verified
- Aug 2018
- First submitted
- 9 Jun 2008
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yentzer B, Hick J, Williams L, Inabinet R, Wilson R, Camacho FT, Russell GB, Feldman SR. Adherence to a topical regimen of 5-fluorouracil, 0.5%, cream for the treatment of actinic keratoses. Arch Dermatol. 2009 Feb;145(2):203-5. doi: 10.1001/archdermatol.2008.562. No abstract available.
PubMed 19221274
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
- ClinicalTrials.gov ID
- NCT00696488
- Acronym / sponsor ID
- IRB00000156
- Conditions
- Actinic Keratosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Posted 27 Mar 2017
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 this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.
Detailed description
The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorouracil 0.5% | Experimental | Drug: Fluorouracil 0.5%each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation.
Key exclusion criteria (6 listed)
- Age less than 50.
- Known allergy or sensitivity to topical Carac® in the subject.
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study.
- Subjects should not receive surgical or cryotherapy while participating in the study.
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 |
|---|---|---|
| Fluorouracil 0.5%Also: CaracSubjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions | Drug | Fluorouracil 0.5% |
Primary outcome
Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.
Time frame: 12 weeks
Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19221274Yentzer B, Hick J, Williams L, Inabinet R, Wilson R, Camacho FT, Russell GB, Feldman SR. Adherence to a topical regimen of 5-fluorouracil, 0.5%, cream for the treatment of actinic keratoses. Arch Dermatol. 2009 Feb;145(2):203-5. doi: 10.1001/archdermatol.2008.562. No abstract available.
- Individual participant dataSharing planned: No
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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.
Steve Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluorouracil 0.5% in people with Actinic Keratosis, run by Wake Forest University 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 6 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 10 Sep 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2017). 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?
Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis. (time frame: 12 weeks). 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 NCT00696488, 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 10 Sep 2018.