NCT01444989

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

September 29, 2011

Last Update Submit

August 13, 2018

Conditions

Actinic Keratosis

Keywords

"Sun spots""Pre-cancerous skin lesion"

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Correlation between AKRQ and DLQI scores

    Baseline

  • The correlation between AKRQ and Skindex-16 scores

    Baseline

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

    Baseline

Study Arms (2)

Patients without actinic keratosis

EXPERIMENTAL

Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.

Other: AKRQ questionnaireOther: Skindex-16, DLQI, Skin Health Calculator

Patients with Actinic Keratosis

EXPERIMENTAL

Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.

Other: AKRQ questionnaireOther: Skindex-16, DLQI, Skin Health Calculator

Interventions

AKRQ questionnaireOTHER

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

Patients with Actinic KeratosisPatients without actinic keratosis
Skindex-16, DLQI, Skin Health CalculatorOTHER

These are all previously validated questionnaires

Patients with Actinic KeratosisPatients without actinic keratosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age 18 years or older being seen in a dermatology clinic
  • Informed consent of participation must be given by subject

You may not qualify if:

  • Inability to complete all study questionnaires.
  • Subjects who are unable to read and write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Health Sciences Dermatology

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Keratosis, ActinicMelanosis

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesHyperpigmentationPigmentation Disorders

Study Officials

  • Steven R Feldman, MD, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 3, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

US(1)