NCT02362152

Brief Summary

This non-interventional, multinational study of topical field treatment of actinic keratosis (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other topical field therapies commonly used in the individual country. Physicians will report baseline characteristics, while the main study focus will be on patient reported outcomes 3-4 weeks after treatment completion (treatment satisfaction, adherence, resource utilization and Health Related Quality of Life. Dermatology centres in Denmark, Norway, Sweden, the Netherlands, the United Kingdom and Canada will participate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,168

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

February 7, 2015

Last Update Submit

December 12, 2019

Conditions

Actinic Keratosis

Keywords

Actinic keratosisSolar keratosisField treatmentIngenol mebutatePicato

Outcome Measures

Primary Outcomes (1)

  • Treatment satisfaction

    Treatment Satisfaction Questionnaire of Medication TSQM 9

    3-4 weeks after end of treatment

Secondary Outcomes (5)

  • Adherence

    3-4 weeks after end of treatment

  • Health Related Quality of Life EQ-5D-5L

    Baseline and 3-4 weeks after end of treatment

  • DLQI

    Baseline and 3-4 weeks after end of treatment

  • WPAI

    3-4 weeks after end of treatment

  • Local Skin Response

    Up to 3-4 weeks after end of treatment

Study Arms (4)

Ingenol mebutate

Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments

Drug: Ingenol mebutate

5-fluorouracil

Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments

Drug: 5-fluorouracil

Imiquimod

Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments

Drug: Imiquimod

Diclofenac

Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments

Drug: Diclofenac

Interventions

Ingenol mebutateDRUG

Topical field treatment as prescribed by dermatologist

Also known as: Picato
Ingenol mebutate
5-fluorouracilDRUG

Topical field treatment as prescribed by dermatologist

Also known as: 5-FU
5-fluorouracil
ImiquimodDRUG

Topical field treatment as prescribed by dermatologist

Imiquimod
DiclofenacDRUG

Topical field treatment as prescribed by dermatologist

Diclofenac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with actinic keratosis planned to receive treatment with ingenol mebutate, 5-fluorouracil, imiquimod or diclofenac at the discretion of the dermatologist (and patient).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lievensberg Ziekenhuis

Bergen op Zoom, 4624, Netherlands

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelateFluorouracilImiquimodDiclofenac

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Study Director Study Director

    LEO Pharma

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2015

First Posted

February 12, 2015

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)