Clinical trial · Interventional
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AKRQ questionnaire | Other | — | UNRESOLVED |
| Skindex-16, DLQI, Skin Health Calculator | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients without actinic keratosis
- description
- Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
- interventionNames
- Other: AKRQ questionnaire
- Other: Skindex-16, DLQI, Skin Health Calculator
- type
- EXPERIMENTAL
- label
- Patients with Actinic Keratosis
- description
- Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.
- interventionNames
- Other: AKRQ questionnaire
- Other: Skindex-16, DLQI, Skin Health Calculator
Primary outcomes (1)
- measure
- Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available