Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Half-dose illumination protocol
  • Full-dose illumination protocol

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations