The Real Life Topical Field Treatment of Actinic Keratosis Study (RAPID-ACT)

The Real Life Topical Field Treatment of Actinic Keratosis Study. An Observational Study Focusing on Patient Reported Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Ingenol mebutate; Drug: 5-fluorouracil; Drug: Imiquimod; Drug: Diclofenac

Detailed Description

Actinic keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to squamous cell carcinoma. AK treatment options include cryotherapy for solitary lesions and topical field therapy or photodynamic therapy for lesions in an area of sun-damaged skin. This prospective, non-interventional, multinational study aims to describe and compare in a real-life setting the treatment satisfaction, treatment adherence, resource utilization and quality of life during topical field treatment of AK with 5-fluorouracil, imiquimod, diclofenac and ingenol mebutate.

Dermatology centres in Denmark, Sweden, Norway, Canada, the United Kingdom and the Netherlands will aim to include a total of approximately 1600 patients, of which around 100 in each country will be patients scheduled to receive treatment with ingenol mebutate. In each country patients will in addition be recruited for one or two of the other treatment arms, as appropriate in the country.

Only adult patients scheduled to start treatment with imiquimod, 5-fluorouracil, diclofenac or ingenol mebutate who have given informed consent to use data from their medical records for the study and to report study data themselves will be included and followed for the duration of the scheduled treatment + 3-4 weeks.

Physician will report patient demographics and AK characteristics at baseline. Patients will at baseline report AK Quality of Life, including general attitude regarding sun damaged skin at baseline, and, if applicable, treatment satisfaction and adherence with latest previous AK treatment. At 3-4 weeks after end of treatment, the patients will report treatment satisfaction, adherence, resource utilization, health related Quality of Life.

Treating physicians report drug-related Adverse Events in accordance with national laws and regulations and normal clinical practice.

• Study Type: Observational
• Enrollment (Actual): 1168

Contacts and Locations

Study Locations

• Netherlands
  • Bergen op Zoom, Netherlands, 4624
    • Lievensberg ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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).

Description

Inclusion Criteria: Patients eligible to receive topical treatment with one of the following for treatment of actinic keratosis at the discretion of the dermatologist: Ingenol mebutate, 5-fluorouracil, imiquimod, diclofenac. Informed consent.

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Exclusion Criteria: Any on-going treatments at study start with ingenol mebutate, 5-fluorouracil, imiquimod or diclofenac; other topical treatment for AK in treatment area; pregnancy or planned pregnancy within treatment period.

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ingenol mebutate; Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments	Drug: Ingenol mebutate; Topical field treatment as prescribed by dermatologist; Other Names: Picato
5-fluorouracil; Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments	Drug: 5-fluorouracil; Topical field treatment as prescribed by dermatologist; Other Names: 5-FU
Imiquimod; Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments	Drug: Imiquimod; Topical field treatment as prescribed by dermatologist
Diclofenac; Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments	Drug: Diclofenac; Topical field treatment as prescribed by dermatologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment satisfaction	Treatment Satisfaction Questionnaire of Medication TSQM 9	3-4 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Morisky Medication Adherence Scale	3-4 weeks after end of treatment
Health Related Quality of Life EQ-5D-5L	General measure of health outcome	Baseline and 3-4 weeks after end of treatment
DLQI	Dermatology Life Quality Index	Baseline and 3-4 weeks after end of treatment
WPAI	Work Productivity and Activity Impairment Questionnaire	3-4 weeks after end of treatment
Local Skin Response	Occurrence and duration of redness of skin, dry skin, burning, or stinging	Up to 3-4 weeks after end of treatment

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Study Director Study Director, LEO Pharma

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 7, 2015
• First Submitted That Met QC Criteria: February 7, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Actinic keratosis; Solar keratosis; Field treatment; Ingenol mebutate; Picato
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Fluorouracil; Imiquimod; Diclofenac
• Other Study ID Numbers: NIS-PICATO-1116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No