Actinic KeratosisRAPID-ACTNCT02362152
The Real Life Topical Field Treatment of Actinic Keratosis Study
An observational study of Actinic Keratosis, run by LEO Pharma at 1 site in Netherlands.
Trial summary
This non-interventional, multinational study of topical field treatment of actinic keratosis (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other topical field therapies commonly used in the individual country. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Ingenol mebutate, 5-fluorouracil and Imiquimod
- How many people
- 1,168 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Dec 2015
- 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: Adult patients diagnosed with actinic keratosis planned to receive treatment with ingenol mebutate, 5-fluorouracil, imiquimod or diclofenac at the discretion of the dermatologist (and patient).
Inclusion Criteria: Patients eligible to receive topical treatment with one of the following for treatment of actinic keratosis at the discretion of the dermatologist: Ingenol mebutate, 5-fluorouracil, imiquimod, diclofenac. Informed consent.
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Exclusion Criteria: Any on-going treatments at study start with ingenol mebutate, 5-fluorouracil, imiquimod or diclofenac; other topical treatment for AK in treatment area; pregnancy or planned pregnancy within treatment period.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Real Life Topical Field Treatment of Actinic Keratosis Study. An Observational Study Focusing on Patient Reported Outcomes
This non-interventional, multinational study of topical field treatment of actinic keratosis (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other topical field therapies commonly used in the individual country. Physicians will report baseline characteristics, while the main study focus will be on patient reported outcomes 3-4 weeks after treatment completion (treatment satisfaction, adherence, resource utilization and Health Related Quality of Life.
Dermatology centres in Denmark, Norway, Sweden, the Netherlands, the United Kingdom and Canada will participate.
Read the detailed description
Actinic keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to squamous cell carcinoma. AK treatment options include cryotherapy for solitary lesions and topical field therapy or photodynamic therapy for lesions in an area of sun-damaged skin. This prospective, non-interventional, multinational study aims to describe and compare in a real-life setting the treatment satisfaction, treatment adherence, resource utilization and quality of life during topical field treatment of AK with 5-fluorouracil, imiquimod, diclofenac and ingenol mebutate.
Dermatology centres in Denmark, Sweden, Norway, Canada, the United Kingdom and the Netherlands will aim to include a total of approximately 1600 patients, of which around 100 in each country will be patients scheduled to receive treatment with ingenol mebutate. In each country patients will in addition be recruited for one or two of the other treatment arms, as appropriate in the country.
Only adult patients scheduled to start treatment with imiquimod, 5-fluorouracil, diclofenac or ingenol mebutate who have given informed consent to use data from their medical records for the study and to report study data themselves will be included and followed for the duration of the scheduled treatment + 3-4 weeks.
Physician will report patient demographics and AK characteristics at baseline. Patients will at baseline report AK Quality of Life, including general attitude regarding sun damaged skin at baseline, and, if applicable, treatment satisfaction and adherence with latest previous AK treatment. At 3-4 weeks after end of treatment, the patients will report treatment satisfaction, adherence, resource utilization, health related Quality of Life.
Treating physicians report drug-related Adverse Events in accordance with national laws and regulations and normal clinical practice.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate, 5-fluorouracil, Imiquimod, Diclofenac
- Keywords
- Actinic keratosis, Solar keratosis, Field treatment, Ingenol mebutate, Picato
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingenol mebutateDrug
Also called Picato
Topical field treatment as prescribed by dermatologist
5-fluorouracilDrug
Also called 5-FU
Topical field treatment as prescribed by dermatologist
ImiquimodDrug
Topical field treatment as prescribed by dermatologist
DiclofenacDrug
Topical field treatment as prescribed by dermatologist
| Study group | Role | What they receive |
|---|---|---|
| Ingenol mebutate | Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments Receives: Drug: Ingenol mebutate | |
| 5-fluorouracil | Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments Receives: Drug: 5-fluorouracil | |
| Imiquimod | Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments Receives: Drug: Imiquimod | |
| Diclofenac | Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment satisfaction
Treatment Satisfaction Questionnaire of Medication TSQM 9
Measured: 3-4 weeks after end of treatment
Secondary outcomes (5)
Adherence
Morisky Medication Adherence Scale
Measured: 3-4 weeks after end of treatment
Health Related Quality of Life EQ-5D-5L
General measure of health outcome
Measured: Baseline and 3-4 weeks after end of treatment
DLQI
Dermatology Life Quality Index
Measured: Baseline and 3-4 weeks after end of treatment
WPAI
Work Productivity and Activity Impairment Questionnaire
Measured: 3-4 weeks after end of treatment
Local Skin Response
Occurrence and duration of redness of skin, dry skin, burning, or stinging
Measured: Up to 3-4 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director Study Director, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362152
- Sponsor's protocol ID
- NIS-PICATO-1116
- Acronym
- RAPID-ACT
- Status last verified
- Dec 2019
- First submitted
- 7 Feb 2015
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real Life Topical Field Treatment of Actinic Keratosis Study. An Observational Study Focusing on Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT02362152
- Acronym / sponsor ID
- RAPID-ACT / NIS-PICATO-1116
- Conditions
- Actinic Keratosis
- Keywords
- Actinic keratosis, Solar keratosis, Field treatment, Ingenol mebutate, Picato
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,168 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Feb 2015 (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 non-interventional, multinational study of topical field treatment of actinic keratosis (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other topical field therapies commonly used in the individual country. Physicians will report baseline characteristics, while the main study focus will be on patient reported outcomes 3-4 weeks after treatment completion (treatment satisfaction, adherence, resource utilization and Health Related Quality of Life.
Dermatology centres in Denmark, Norway, Sweden, the Netherlands, the United Kingdom and Canada will participate.
Detailed description
Actinic keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to squamous cell carcinoma. AK treatment options include cryotherapy for solitary lesions and topical field therapy or photodynamic therapy for lesions in an area of sun-damaged skin. This prospective, non-interventional, multinational study aims to describe and compare in a real-life setting the treatment satisfaction, treatment adherence, resource utilization and quality of life during topical field treatment of AK with 5-fluorouracil, imiquimod, diclofenac and ingenol mebutate.
Dermatology centres in Denmark, Sweden, Norway, Canada, the United Kingdom and the Netherlands will aim to include a total of approximately 1600 patients, of which around 100 in each country will be patients scheduled to receive treatment with ingenol mebutate. In each country patients will in addition be recruited for one or two of the other treatment arms, as appropriate in the country.
Only adult patients scheduled to start treatment with imiquimod, 5-fluorouracil, diclofenac or ingenol mebutate who have given informed consent to use data from their medical records for the study and to report study data themselves will be included and followed for the duration of the scheduled treatment + 3-4 weeks.
Physician will report patient demographics and AK characteristics at baseline. Patients will at baseline report AK Quality of Life, including general attitude regarding sun damaged skin at baseline, and, if applicable, treatment satisfaction and adherence with latest previous AK treatment. At 3-4 weeks after end of treatment, the patients will report treatment satisfaction, adherence, resource utilization, health related Quality of Life.
Treating physicians report drug-related Adverse Events in accordance with national laws and regulations and normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ingenol mebutate | – | Drug: Ingenol mebutateAdults with actinic keratosis eligible to receive topical treatment with one of the four treatments |
| 5-fluorouracil | – | Drug: 5-fluorouracilAdults with actinic keratosis eligible to receive topical treatment with one of the four treatments |
| Imiquimod | – | Drug: ImiquimodAdults with actinic keratosis eligible to receive topical treatment with one of the four treatments |
| Diclofenac | – | Drug: DiclofenacAdults with actinic keratosis eligible to receive topical treatment with one of the four treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with actinic keratosis planned to receive treatment with ingenol mebutate, 5-fluorouracil, imiquimod or diclofenac at the discretion of the dermatologist (and patient).
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 |
|---|---|---|
| Ingenol mebutateAlso: PicatoTopical field treatment as prescribed by dermatologist | Drug | Ingenol mebutate |
| 5-fluorouracilAlso: 5-FUTopical field treatment as prescribed by dermatologist | Drug | 5-fluorouracil |
| ImiquimodTopical field treatment as prescribed by dermatologist | Drug | Imiquimod |
| DiclofenacTopical field treatment as prescribed by dermatologist | Drug | Diclofenac |
Primary outcome
Treatment satisfaction
Time frame: 3-4 weeks after end of treatment
Treatment Satisfaction Questionnaire of Medication TSQM 9
5 secondary outcomes
Adherence
Time frame: 3-4 weeks after end of treatment
Health Related Quality of Life EQ-5D-5L
Time frame: Baseline and 3-4 weeks after end of treatment
DLQI
Time frame: Baseline and 3-4 weeks after end of treatment
WPAI
Time frame: 3-4 weeks after end of treatment
Local Skin Response
Time frame: Up to 3-4 weeks after end of treatment
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 13 Dec 2019.
- 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.
Study Director Study Director study director
LEO Pharma
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 Actinic Keratosis, run by LEO Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Dec 2019. 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 Netherlands. 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.
What does the primary outcome measure?
Treatment satisfaction (time frame: 3-4 weeks after end of treatment). 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 13 Dec 2019.