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NCT01444989 · ClinicalTrials.gov registry record · NA
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
A NA study, sponsored by Wake Forest University.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT01444989: Completed NA study, sponsored by Wake Forest University.
NCT01444989 is a NA study that has completed, run by Wake Forest University. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01444989, a NA study, has completed, sponsored by Wake Forest University.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER AKRQ questionnaire
- OTHER Skindex-16, DLQI, Skin Health Calculator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-03 |
| Phase | NA |
What the finished NCT01444989 record still lists
NCT01444989 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which AKRQ questionnaire is the first listed.
NCT01444989 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01444989 about?
NCT01444989 is a clinical study titled "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 psychosoc...
What is the current status of trial NCT01444989?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2011-09. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01444989?
The interventions under investigation include: AKRQ questionnaire (OTHER), Skindex-16, DLQI, Skin Health Calculator (OTHER).
Who is sponsoring clinical trial NCT01444989?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01444989's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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