TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life… (NCT04202445) | Clinical Trial Compass
CompletedNot Applicable
TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction
1,218 participantsStarted 2014-04
Plain-language summary
This is an observational longitudinal study, prospective, multicenter, performed in metropolitan France, on a representative sample of dermatologists.
Data will be collected by physicians during 2 or 3 visits (according to their usual practice), from the patient file, questioning and clinical examination performed during these visits.
Data about the patient's perception (satisfaction, perception of local skin reactions, quality of life) will be collected directly by the patient using self-administered questionnaires at inclusion visit, day 7 and 2 months later.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient at least 18 years old, seen by the dermatologist during a consultation, whether actinic keratosis is the reason for consultation or not.
* Patient with AK lesions and for whom the dermatologist decided to initiate a treatment with Picato®\* 150 or Picato®\* 500
* Patient informed and accepting the automatic processing of medical data \* To respect the physicians' independence, this study is conducted among patients for whom the decision of therapeutic care is not related to their inclusion.
Exclusion Criteria:
* Patient with a contraindication to treatment with Picato®.
* Patient unable to read and/or to understand a self-administered questionnaire.
* Patient already included in the study.
* Patient participating or having participated in the previous month in a clinical trial in dermatology.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Satisfaction Questionnaire of Medication (TSQM-9)