Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02362152
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.


Condition or disease Intervention/treatment
Actinic Keratosis 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1168 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Real Life Topical Field Treatment of Actinic Keratosis Study. An Observational Study Focusing on Patient Reported Outcomes
Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Treatment satisfaction [ Time Frame: 3-4 weeks after end of treatment ]
    Treatment Satisfaction Questionnaire of Medication TSQM 9


Secondary Outcome Measures :
  1. Adherence [ Time Frame: 3-4 weeks after end of treatment ]
    Morisky Medication Adherence Scale

  2. Health Related Quality of Life EQ-5D-5L [ Time Frame: Baseline and 3-4 weeks after end of treatment ]
    General measure of health outcome

  3. DLQI [ Time Frame: Baseline and 3-4 weeks after end of treatment ]
    Dermatology Life Quality Index

  4. WPAI [ Time Frame: 3-4 weeks after end of treatment ]
    Work Productivity and Activity Impairment Questionnaire

  5. Local Skin Response [ Time Frame: Up to 3-4 weeks after end of treatment ]
    Occurrence and duration of redness of skin, dry skin, burning, or stinging



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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.

-

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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362152


Locations
Layout table for location information
Netherlands
Lievensberg Ziekenhuis
Bergen op Zoom, Netherlands, 4624
Sponsors and Collaborators
LEO Pharma
Investigators
Layout table for investigator information
Study Director: Study Director Study Director LEO Pharma
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02362152    
Other Study ID Numbers: NIS-PICATO-1116
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by LEO Pharma:
Actinic keratosis
Solar keratosis
Field treatment
Ingenol mebutate
Picato
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Diclofenac
Fluorouracil
Imiquimod
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Interferon Inducers