Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses
NCT ID: NCT06545396
Last Updated: 2024-08-09
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-08-31
2025-03-31
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* ≥ 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 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.
18 Years
ALL
No
Sponsors
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
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Jorge Naharro-Rodriguez
Principal Investigator
Principal Investigators
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Jorge Naharro-Rodriguez, M.D.
Role: PRINCIPAL_INVESTIGATOR
No organization
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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154/23
Identifier Type: -
Identifier Source: org_study_id
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