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

NCT06545396 | Not Yet Recruiting

• 1 other identifier: 154/23
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Actinic Keratoses

Keywords

Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

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

  Total count of actinic keratosis will be assessed

  3 months after de procedure

Secondary Outcomes (2)

• Tolerance during intervention

  During the procedure

• Histological grade of actinic keratosis in biopsies as well as relevant biomarkers

  3 months after the procedure

Study Arms (2)

Conventional photodynamic therapy with red light and methyl aminolevulinate

ACTIVE COMPARATOR

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

Half-dose illumination protocol photodynamic therapy with red light and methyl aminolevulinate

EXPERIMENTAL

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

Interventions

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.

Half-dose illumination protocol photodynamic therapy with red light and methyl aminolevulinate

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.

Conventional photodynamic therapy with red light and methyl aminolevulinate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Related Publications (11)

• Trakatelli M, Ulrich C, del Marmol V, Euvrard S, Stockfleth E, Abeni D. Epidemiology of nonmelanoma skin cancer (NMSC) in Europe: accurate and comparable data are needed for effective public health monitoring and interventions. Br J Dermatol. 2007 May;156 Suppl 3:1-7. doi: 10.1111/j.1365-2133.2007.07861.x.

  PMID: 17488399 RESULT

• Rowert-Huber J, Patel MJ, Forschner T, Ulrich C, Eberle J, Kerl H, Sterry W, Stockfleth E. Actinic keratosis is an early in situ squamous cell carcinoma: a proposal for reclassification. Br J Dermatol. 2007 May;156 Suppl 3:8-12. doi: 10.1111/j.1365-2133.2007.07860.x.

  PMID: 17488400 RESULT

• Wheller L, Soyer HP. Clinical features of actinic keratoses and early squamous cell carcinoma. Curr Probl Dermatol. 2015;46:58-63. doi: 10.1159/000366536. Epub 2014 Dec 18.

  PMID: 25561207 RESULT

• Siegel JA, Korgavkar K, Weinstock MA. Current perspective on actinic keratosis: a review. Br J Dermatol. 2017 Aug;177(2):350-358. doi: 10.1111/bjd.14852. Epub 2016 Aug 8.

  PMID: 27500794 RESULT

• Chen SC, Hill ND, Veledar E, Swetter SM, Weinstock MA. Reliability of quantification measures of actinic keratosis. Br J Dermatol. 2013 Dec;169(6):1219-22. doi: 10.1111/bjd.12591.

  PMID: 24033340 RESULT

• Schmitz L, Gupta G, Stucker M, Doerler M, Gambichler T, Welzel J, Szeimies RM, Bierhoff E, Stockfleth E, Dirschka T. Evaluation of two histological classifications for actinic keratoses - PRO classification scored highest inter-rater reliability. J Eur Acad Dermatol Venereol. 2019 Jun;33(6):1092-1097. doi: 10.1111/jdv.15580. Epub 2019 Apr 3.

  PMID: 30887613 RESULT

• Willenbrink TJ, Ruiz ES, Cornejo CM, Schmults CD, Arron ST, Jambusaria-Pahlajani A. Field cancerization: Definition, epidemiology, risk factors, and outcomes. J Am Acad Dermatol. 2020 Sep;83(3):709-717. doi: 10.1016/j.jaad.2020.03.126. Epub 2020 May 7.

  PMID: 32387665 RESULT

• Fernandez-Guarino M, Fonda Pascual P, Lizuain Gomez P, Harto Castano A, Jaen Olasolo P. Split-face study comparing conventional MAL photodynamic therapy in multiple actinic keratosis with complete time vs. half-time red light LED conventional illumination. J Eur Acad Dermatol Venereol. 2019 Aug;33(8):1529-1534. doi: 10.1111/jdv.15566. Epub 2019 Apr 15.

  PMID: 30868672 RESULT

• Novak B, Heesen L, Schary N, Lubbert H. The influence of different illumination parameters on protoporphyrin IX induced cell death in squamous cell carcinoma cells. Photodiagnosis Photodyn Ther. 2018 Mar;21:385-392. doi: 10.1016/j.pdpdt.2018.02.007. Epub 2018 Feb 7.

  PMID: 29427796 RESULT

• Campione E, Di Prete M, Di Raimondo C, Costanza G, Palumbo V, Garofalo V, Mazzilli S, Franceschini C, Dika E, Bianchi L, Orlandi A. Topical Treatment of Actinic Keratosis and Metalloproteinase Expression: A Clinico-Pathological Retrospective Study. Int J Mol Sci. 2022 Sep 26;23(19):11351. doi: 10.3390/ijms231911351.

  PMID: 36232651 RESULT

• Bobyr I, Campanati A, Consales V, Martina E, Molinelli E, Diotallevi F, Brisigotti V, Giangiacomi M, Ganzetti G, Giuliodori K, Offidani A. Ingenol mebutate in actinic keratosis: a clinical, videodermoscopic and immunohistochemical study. J Eur Acad Dermatol Venereol. 2017 Feb;31(2):260-266. doi: 10.1111/jdv.13831. Epub 2016 Jul 25.

  PMID: 27453064 RESULT

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jorge Naharro-Rodriguez, M.D.

  No organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Naharro-Rodriguez, M.D.

CONTACT

913368000; irycis@irycis.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share