- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01444989
Development and Validation of a Quality of Life Instrument for Actinic Keratosis (AKRQ)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27104
- Wake Forest Health Sciences Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients without actinic keratosis
Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
|
The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
These are all previously validated questionnaires
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Experimental: Patients with Actinic Keratosis
Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.
|
The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
These are all previously validated questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Baseline
|
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
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00017619
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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