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Development and Validation of a Quality of Life Instrument for Actinic Keratosis

Development and Validation of a Quality of Life Instrument for Actinic Keratosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01444989
Acronym
AKRQ
Enrollment
150
Registered
2011-10-03
Start date
2011-09-30
Completion date
2012-03-31
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Sun spots, Pre-cancerous skin lesion

Brief 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. 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.

Interventions

OTHERAKRQ questionnaire

The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors

OTHERSkindex-16, DLQI, Skin Health Calculator

These are all previously validated questionnaires

Sponsors

Wake Forest University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Male or female, age 18 years or older being seen in a dermatology clinic * Informed consent of participation must be given by subject

Exclusion criteria

* Inability to complete all study questionnaires. * Subjects who are unable to read and write English

Design outcomes

Primary

MeasureTime frameDescription
Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosisBaselineWe 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.

Secondary

MeasureTime frameDescription
Correlation between AKRQ and DLQI scoresBaselineThe DLQI is a validated instrument. We will report how well our new instrument correlates with the DLQI.
The correlation between AKRQ and Skindex-16 scoresBaselineThe Skindex-16 is a validated instrument. We will report how well our new instrument correlates with the Skindex-16.
The correlation between the AKRQ and Skin Health Calculator scores.BaselineThe Skin health calculator is a validated instrument. We will report how well our new instrument correlates with the Skin Health Calculator

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026