NCT01444989

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
OTHER	AKRQ questionnaire	The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
OTHER	Skindex-16, DLQI, Skin Health Calculator	These are all previously validated questionnaires

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2011-10-03
• Last updated: 2018-08-15

Locations

1 site across 1 country: United States