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

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe a lower dose of red light treatment is for a skin condition called actinic keratoses, which are rough patches on the skin caused by sun damage. The researchers want to find out if using half the usual amount of light during a treatment called photodynamic therapy (PDT) still works well and is easier for patients to handle. To do this, they will treat one side of a participant's scalp with the standard light dose and the other side with the lower dose, and then take small skin samples to see how both treatments affect the skin at a deeper level.

To join the study, participants need to be at least 18 years old and have multiple actinic keratoses on their scalp that need treatment. They should have had more than five of these patches and not received treatment in the last six months. People with certain skin conditions, those allergic to a specific medication used in the treatment, or those unable to give consent will not be eligible. Throughout the trial, participants will have three visits where they will receive treatment and undergo assessments to monitor their progress and any side effects.

Gender

ALL

Eligibility criteria

• 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.