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

Actinic Keratosis Clinical Trial

— AKRQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444989
• Other study ID #: IRB00017619
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	Correlation between AKRQ and DLQI scores	The DLQI is a validated instrument. We will report how well our new instrument correlates with the DLQI.	Baseline
Secondary	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.	Baseline
Secondary	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	Baseline