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      Randomized Clinical Trial of Conventional versus Indoor Daylight Photodynamic Therapy for Treatment of Actinic Cheilitis

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          Abstract

          Introduction

          Actinic cheilitis (AC) is the biologic precursor of invasive squamous cell carcinoma (SCC) of the vermilion, and different treatment options have been investigated, but their efficacy is hampered by local inflammation, pain and slow recovery. Daylight photodynamic therapy (dl-PDT) has been demonstrated to represent a valuable treatment option for AC, but its feasibility is limited by weather conditions and latitude.

          Methods

          Our study proposed to compare the efficacy and tolerability of conventional photodynamic therapy (c-PDT) and indoor daylight photodynamic therapy (idl-PDT) with a white LED lamp for the treatment of AC. Sixteen patients were enrolled in the study: 8 (50%) treated with c-PDT and 8 (50%) treated with idl-PDT. All patients completed the study protocol.

          Results

          Both idl-PDT and c-PDT were demonstrated to be highly effective in terms of reduction of the cumulative lesional area and severity of the clinical score. Neither treatment was inferior to the other. The inflammatory reaction and the pain scores were milder with idl-PDT, whereas the cosmetic outcome was not different.

          Conclusion

          The present findings confirm that idl-PDT can represent a valid therapeutic strategy for AC patients as well, despite the procedural difficulties and the risk of poor tolerability related to the body site.

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          Most cited references35

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          Actinic cheilitis: clinical and pathologic characteristics in 65 cases.

          A Markopoulos, E Albanidou-Farmaki, I Kayavis (2004)
          The purpose of this study was to determine the clinical and histopathologic presentation of actinic cheilitis. A retrospective study on 65 patients attending an Oral Medicine clinic in Greece over a 10 year period. For each case the demographic, clinical and histopathologic information were evaluated. The mean age at the time of diagnosis was 53.1 +/- 11.4 years. Thirty-nine patients (60%) used tobacco in any form. An outdoor occupation was indicated for 43 (66.2%) patients. The location of the lesions of actinic cheilitis was in all cases on the lower lip. Actinic cheilitis appeared in three forms; white non-ulcerated lesions (29%), erosions or ulcers of the lip (48%), mixed white and erosive (23%). The histopathologic characteristics included increased thickness of keratin layer, alterations of the thickness of spinous cell layer, epithelial dysplasia, connective tissue changes, perivascular inflammation and basophilic changes of connective tissue. In 11 cases (16.9%) the presence of squamous cell carcinoma was observed. This case-series highlights varied clinical presentation of actinic cheilitis among whom a high proportion developed squamous cell carcinoma.
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            A Network Meta-Analysis of the Relative Efficacy of Treatments for Actinic Keratosis of the Face or Scalp in Europe

            Stefan Vegter, Keith Tolley (2014)
            Background Several treatments are available for actinic keratosis (AK) on the face and scalp. Most treatment modalities were compared to placebo and therefore little is known on their relative efficacy. Objectives To compare the different treatments for mild to moderate AK on the face and scalp available in clinical practice in Europe. Methods A network meta-analysis (NMA) was performed on the outcome “complete patient clearance”. Ten treatment modalities were included: two 5-aminolaevulinic acid photodynamic therapies (ALA-PDT), applied as gel (BF-200 ALA) or patch; methyl-aminolevulinate photodynamic therapy (MAL-PDT); three modalities with imiquimod (IMI), applied as a 4-week or 16-week course with 5% imiquimod, or a 2–3 week course with 3.75% imiquimod; cryotherapy; diclofenac 3% in 2.5% hyaluronic acid; 0.5% 5-fluorouracil (5-FU); and ingenol mebutate (IMB). The only data available for 5% 5-FU was from one small study and was determined to be too limited to be reliably included in the analysis. For BF-200 ALA and MAL-PDT, data from illumination with narrow-band lights were selected as these are typically used in clinical practice. The NMA was performed with a random-effects Bayesian model. Results 25 trials on 5,562 patients were included in the NMA. All active treatments were significantly better than placebo. BF-200 ALA showed the highest efficacy compared to placebo to achieve total patient clearance. BF-200 ALA had the highest probability to be the best treatment and the highest SUCRA score (64.8% and 92.1%), followed by IMI 5% 4 weeks (10.1% and 74.2%) and 5-FU 0.5% (7.2% and 66.8%). Conclusions This NMA showed that BF-200 ALA, using narrow-band lights, was the most efficacious treatment for mild to moderate AK on the face and scalp. This analysis is relevant for clinical decision making and health technology assessment, assisting the improved management of AK.
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              Photodynamic therapy of actinic keratoses with 8% and 16% methyl aminolaevulinate and home-based daylight exposure: a double-blinded randomized clinical trial.

              S R Wiegell, M. Hædersdal, P Eriksen … (2009)
              Photodynamic therapy (PDT) is an effective but time-consuming and often painful treatment for actinic keratosis (AK). Home-based daylight-PDT has the potential to facilitate treatment procedure and to reduce associated pain due to continuous activation of small amounts of porphyrins. Moreover, a reduced methyl aminolaevulinate (MAL) concentration may reduce associated inflammation, making the treatment more tolerable for the patients.
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                Author and article information

                Contributors
                Mariachiara Arisi:
                ORCID: http://orcid.org/0000-0001-6307-6174
                mariachiara.arisi@gmail.com
                Journal
                Journal ID (nlm-ta): Dermatol Ther (Heidelb)
                Journal ID (iso-abbrev): Dermatol Ther (Heidelb)
                Title: Dermatology and Therapy
                Publisher: Springer Healthcare (Cheshire )
                ISSN (Print): 2193-8210
                ISSN (Electronic): 2190-9172
                Publication date (Electronic): 30 July 2022
                Publication date PMC-release: 30 July 2022
                Publication date Collection: September 2022
                Volume: 12
                Issue: 9
                Pages: 2049-2061
                Affiliations
                [1 ]GRID grid.7637.5, ISNI 0000000417571846, Dermatology Department, , University of Brescia, ASST Spedali Civili di Brescia, ; P. Le Spedali Civili 1, 25123 Brescia, Italy
                [2 ]GRID grid.412725.7, Medical Physics Department, , ASST Spedali Civili di Brescia, ; Brescia, Italy
                Author information
                http://orcid.org/0000-0001-6307-6174
                Article
                Publisher ID: 783
                DOI: 10.1007/s13555-022-00783-1
                PMC ID: 9464288
                PubMed ID: 35907163
                SO-VID: b1e2077f-4c09-4e2a-b73e-f424428da1d8
                Copyright © © The Author(s) 2022
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 16 May 2022
                Date accepted : 18 July 2022
                Categories
                Subject: Original Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2022

                ScienceOpen disciplines: Dermatology
                Keywords: actinic cheilitis,photodynamic therapy,conventional photodynamic therapy,daylight photodynamic therapy,indoor daylight photodynamic therapy
                Data availability:
                ScienceOpen disciplines: Dermatology
                Keywords: actinic cheilitis, photodynamic therapy, conventional photodynamic therapy, daylight photodynamic therapy, indoor daylight photodynamic therapy

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