Actinic KeratosisAKRQNCT01444989
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
A study testing AKRQ questionnaire and Skindex-16, DLQI, Skin Health Calculator in people with Actinic Keratosis, run by Wake Forest University at 1 site in United States.
Trial summary
Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- AKRQ questionnaire and Skindex-16, DLQI, Skin Health Calculator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2012
- Phase
- Interventional
- 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
- Male or female, age 18 years or older being seen in a dermatology clinic
- Informed consent of participation must be given by subject
Who cannot join
- Inability to complete all study questionnaires.
- Subjects who are unable to read and write English
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences Dermatology
Winston-Salem, North Carolina, 27104
About this study
Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. While they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. At the same time, AKs are known to progress in a significant number of cases to squamous cell carcinoma (SCC), a concern in terms of its metastatic potential.
The primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. However, since AK is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to AK but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without AKs, defined as the control population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as well as a questionnaire composed of items specific to predisposition to AKs to be able to better assess the discriminatory power of the questionnaire.
- Conditions
- Actinic Keratosis
- Being tested
- AKRQ questionnaire, Skindex-16, DLQI, Skin Health Calculator
- Keywords
- "Sun spots", "Pre-cancerous skin lesion"
- Medical subject headings
- Keratosis, Actinic, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKRQ questionnaireOther
The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
Skindex-16, DLQI, Skin Health CalculatorOther
These are all previously validated questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients without actinic keratosis | Experimental | Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire. Receives: Other: AKRQ questionnaire; Other: Skindex-16, DLQI, Skin Health Calculator |
| Patients with Actinic Keratosis | Experimental | Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire. Receives: Other: AKRQ questionnaire; Other: Skindex-16, DLQI, Skin Health Calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis
We are developing an actinic keratosis risk assessment questionnaire and is designed to distinguish patients who have a higher likelihood of having a diagnosis of actinic keratosis. The outcome measure is the difference in scores between those with actinic keratosis and those without.
Measured: Baseline
Secondary outcomes (3)
Correlation between AKRQ and DLQI scores
The DLQI is a validated instrument. We will report how well our new instrument correlates with the DLQI.
Measured: Baseline
The correlation between AKRQ and Skindex-16 scores
The Skindex-16 is a validated instrument. We will report how well our new instrument correlates with the Skindex-16.
Measured: Baseline
The correlation between the AKRQ and Skin Health Calculator scores.
The Skin health calculator is a validated instrument. We will report how well our new instrument correlates with the Skin Health Calculator
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionMar 2012
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444989
- Sponsor's protocol ID
- IRB00017619
- Acronym
- AKRQ
- Status last verified
- Aug 2018
- First submitted
- 29 Sep 2011
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Quality of Life Instrument for Actinic Keratosis
- ClinicalTrials.gov ID
- NCT01444989
- Acronym / sponsor ID
- AKRQ / IRB00017619
- Conditions
- Actinic Keratosis
- Keywords
- "Sun spots", "Pre-cancerous skin lesion"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Oct 2011 (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.
Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. While they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. At the same time, AKs are known to progress in a significant number of cases to squamous cell carcinoma (SCC), a concern in terms of its metastatic potential.
The primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. However, since AK is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to AK but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without AKs, defined as the control population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as well as a questionnaire composed of items specific to predisposition to AKs to be able to better assess the discriminatory power of the questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without actinic keratosis | Experimental | Other: AKRQ questionnaire, Other: Skindex-16, DLQI, Skin Health CalculatorPatients with out the diagnosis of actinic keratosis will receive the experimental questionnaire. |
| Patients with Actinic Keratosis | Experimental | Other: AKRQ questionnaire, Other: Skindex-16, DLQI, Skin Health CalculatorPatients with the diagnosis of actinic keratosis will receive the experimental questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, age 18 years or older being seen in a dermatology clinic
- Informed consent of participation must be given by subject
Key exclusion criteria (2 listed)
- Inability to complete all study questionnaires.
- Subjects who are unable to read and write English
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 |
|---|---|---|
| AKRQ questionnaireThe AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors | Other | Patients with Actinic Keratosis, Patients without actinic keratosis |
| Skindex-16, DLQI, Skin Health CalculatorThese are all previously validated questionnaires | Other | Patients with Actinic Keratosis, Patients without actinic keratosis |
Primary outcome
Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis
Time frame: Baseline
We are developing an actinic keratosis risk assessment questionnaire and is designed to distinguish patients who have a higher likelihood of having a diagnosis of actinic keratosis. The outcome measure is the difference in scores between those with actinic keratosis and those without.
3 secondary outcomes
Correlation between AKRQ and DLQI scores
Time frame: Baseline
The correlation between AKRQ and Skindex-16 scores
Time frame: Baseline
The correlation between the AKRQ and Skin Health Calculator scores.
Time frame: Baseline
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 15 Aug 2018.
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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.
Steven R 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 study testing AKRQ questionnaire and Skindex-16, DLQI, Skin Health Calculator 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 2 inclusion and 2 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 15 Aug 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.
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?
Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis (time frame: Baseline). 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 15 Aug 2018.