Clinical trial · Interventional
Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Full-dose illumination protocol | Other | — | UNRESOLVED |
| Half-dose illumination protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional photodynamic therapy with red light and methyl aminolevulinate
- description
- 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.
- interventionNames
- Other: Full-dose illumination protocol
- type
- EXPERIMENTAL
- label
- Half-dose illumination protocol photodynamic therapy with red light and methyl aminolevulinate
- description
- 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.
- interventionNames
- Other: Half-dose illumination protocol
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- RESULTTrakatelli 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
- RESULTRowert-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
- RESULTWheller 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
- RESULTSiegel 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
- RESULTChen 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
- RESULTSchmitz 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
- RESULTWillenbrink 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.