An interventional study of AKRQ questionnaire and Skindex-16, DLQI, Skin Health Calculator in Actinic Keratosis, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-15.
Sponsored by Wake Forest University · Not applicable, Interventional, and Other
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.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
Other: AKRQ questionnaire · Other: Skindex-16, DLQI, Skin Health Calculator
Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.
Other: AKRQ questionnaire · Other: Skindex-16, DLQI, Skin Health Calculator
The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
These are all previously validated questionnaires
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.
Time frame: Baseline
Correlation between AKRQ and DLQI scores
The DLQI is a validated instrument. We will report how well our new instrument correlates with the DLQI.
Time frame: 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.
Time frame: 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
Time frame: Baseline
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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