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NCT Number: NCT06545396

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

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The goal of the clinical trial is to compare efficacy and tolerance of photodynamic therapy (PDT) with red light at half dose illumination protocol with conventional PDT for the treatment of grade I and II actinic keratosis. The main hypotheses is that half-light protocol PDT could maintain efficacy while improving tolerance of the procedure.

With this aim the investigators will compare the efficacy of the clinical response after field treatment with photodynamic therapy with red light at half dose versus conventional photodynamic therapy with standard red light in patients with scalp actinic keratoses as well as determine changes in molecular biomarkers at the histological and immunohistochemical level pre- and post-treatment with conventional PDT and PDT with red light at half dose.

The included patients will have their scalp divided into two halves of similar size using the interparietal line as a separation method; one half will be treated with conventional PDT and the other half with half-dose PDT. This is a comparative study between two treatment modalities, both of which will be applied to all patients, and in half of the sample, four skin biopsies of the affected area (two pre and tw post-treatment) will also be performed to conduct an immunohistochemical analysis of the skin samples. Both treatment protocols will be compared using the patient as his or her own protocol. Variables will be assessed during the 3 visits of the study (baseline, 3 months and 6 months).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Half-dose illumination protocol

Other

Area will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 18,5J/cm2, with the illumination intensity being less than 200 mW/cm2.

Full-dose illumination protocol

Other

Area will be treated according to the classic protocol, in a single session. First, the surface of the actinic keratoses will be scraped to remove scales and crusts. Using a spatula, a sufficient amount of photosensitizing cream will be applied to cover the treatment area (1 mm thick). The treated area will then be covered with an occlusive dressing for 3 hours. After this interval, the dressing will be removed and the area will be exposed to a red light source for 8 minutes with a spectrum of 630 nm and 37J/cm2, with the illumination intensity being less than 200 mW/cm2.

Primary outcomes

Response of 75% of the treated actinic keratosis at 3 months post-intervention.

Time frame: 3 months after de procedure

Total count of actinic keratosis will be assessed

Secondary outcomes

Tolerance during intervention

Time frame: During the procedure

Pain assessed by Visual Analogue Scale (VAS), from 0 (no pain) to 10 (worst pain)
Histological grade of actinic keratosis in biopsies as well as relevant biomarkers

Time frame: 3 months after the procedure

E-cadherin, MMPs, p53, UEA, HSP47 and CD117/c-kit presence on the tissue (from + to +++, depending on the intensity)

Study contacts

Contact information is provided by the study sponsor or research team.

Jorge Naharro-Rodriguez, M.D.

CONTACT

[email protected]

913368000 ext. +34

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

Characterization Of The Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For The Treatment Of Actinic Keratoses And Their Cancerization Field

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 9, 2024
Registry last updated: Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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