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

August 7, 2024 updated by: Jorge Naharro-Rodriguez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jorge Naharro-Rodriguez, M.D.
  • Phone Number: +34 913368000
  • Email: irycis@irycis.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional photodynamic therapy with red light and methyl aminolevulinate
PDT exposing the area 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.
Other: Full-dose illumination protocol
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.
Experimental: Half-dose illumination protocol photodynamic therapy with red light and methyl aminolevulinate
PDT exposing the area 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.
Other: Half-dose illumination protocol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after de procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance during intervention
Time Frame: During the procedure
Pain assessed by Visual Analogue Scale (VAS), from 0 (no pain) to 10 (worst pain)
During the procedure
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)
3 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Investigators

  • Principal Investigator: Jorge Naharro-Rodriguez, M.D., No organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 154/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Actinic Keratoses

Clinical Trials on Full-dose illumination protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe