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OpenTrials
Completed

NCT Number: NCT01444989

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Health Sciences Dermatology

Winston-Salem, North Carolina, 27104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AKRQ questionnaire

Other

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

Skindex-16, DLQI, Skin Health Calculator

Other

These are all previously validated questionnaires

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correlation between AKRQ and DLQI scores

    Time frame: Baseline

    The DLQI is a validated instrument. We will report how well our new instrument correlates with the DLQI.

  2. The correlation between AKRQ and Skindex-16 scores

    Time frame: Baseline

    The Skindex-16 is a validated instrument. We will report how well our new instrument correlates with the Skindex-16.

  3. The correlation between the AKRQ and Skin Health Calculator scores.

    Time frame: Baseline

    The Skin health calculator is a validated instrument. We will report how well our new instrument correlates with the Skin Health Calculator

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Acronym: AKRQ

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 3, 2011
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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