Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic … (NCT06545396) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses
20 participantsStarted 2024-08
Plain-language summary
The goal of this clinical trial is to compare the tolerance and efficacy of conventional photodynamic therapy (PDT) with red light versus PDT with red light at half dose of illumination, as well as the changes produced by both interventions at the biomolecular level in patients with multiple actinic keratosis on the scalp. The main questions it aims to answer are:
Does PDT with half-dose illumination protocol maintain clinical and biomolecular efficacy?
Does PDT with half-dose illumination protocol improve intervention tolerance?
Researchers will compare both treatment protocols using the patient as its own control.
Participants scalp will be divided in two halves, one will be treated with PDT at conventional doses and the other with the half-dose illumination protocol, a skin biopsy will be obtained both pre and post-treatment of each of the areas. Variables will be assessed during the 3 visits of the study.
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 with grade I and II actinic keratoses (AK) of Olsen on the scalp requiring field cancerization treatment.
* ≥ 18 years old.
* More than 5 AK per field of cancerization to be treated.
* More than 6 months since the last field treatment for AK performed.
* No AK in clinical grade III progression of Olsen or showing signs suggestive of being invasive squamous cell carcinoma.
Exclusion Criteria:
* Patients with photodermatoses.
* Patients sensitive to methyl-aminolevulinate.
* Patients with disabilities or unable to provide informed consent.
* Patients who do not tolerate or do not wish to be treated with PDT.
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
Response of 75% of the treated actinic keratosis at 3 months post-intervention.
Timeframe: 3 months after de procedure
Trial details
NCT IDNCT06545396
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal