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`Randomized Controlled Trial
`> J Eur Acad Dermatol Venereol. 2009 Sep;23(9):1061-5.
`FULL TEXT LINKS
`
`doi: 10.1111/j.1468-3083.2009.03259.x. Epub 2009 Apr8.lWwiteyBee
`
`Intraindividual, right-left comparison of topical 5-
`aminolevulinic acid photodynamic therapyvs. 5%
`imiquimod cream for actinic keratoses on the upper
`extremities
`
`_—
`
`
`
`E Sotiriou ', 7 Apalla, F Maliamani, N Zaparas, D Panagiotidou, D loannides
`Affiliations + expand
`PMID: 19470041 DOI: 10.1111/).1468-3083.2009.03259.x
`
`Abstract
`
`Background: Actinic keratoses (AKs) are considered as in situ squamous cell carcinoma. Early and
`effective treatmentis important. Objective To compare the efficacy, cosmetic outcome and patient
`preference of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) with that of 5% imiquimod
`(IMIQ) cream in patients with AKs on the dorsa of hands and forearms.
`Methods: Subjects received two ALA-PDTtreatment sessions and one or two courses of imiquimod
`(three times per week for 4 weeks each). Treatments were randomly allocated to alternate upper
`extremities. Assessments included lesion response one and six monthsafter treatment, cosmetic
`outcome evaluated by the investigators and patients’ preference 6 months after treatment. Efficacy
`end point included the individual AK lesion clearance rate.
`
`Results: Thirty patients with 256 lesions were included in the study. At the first follow-up, treatment
`with ALA-PDTresulted in significantly larger rate of cured lesionsrelative to 5% IMIQ cream (70.16%
`vs. 18.2696). At the second follow-up both treatments showed a high rate of cured lesions (65.32% for
`PDTvs. 55.65% for IMIQ cream). Response rates obtained in grade | lesions were higher for both
`treatments (71.64% for PDT vs. 72.13% for IMIQ), while treatment with PDT resultedin a significant
`larger rate of cured gradeII lesions (57.89% for PDT vs. 37.03 for IMIQ). Difference in cosmetic
`outcome was notstatistically significant. Results for subject preference favoured ALA-PDT.
`
`Conclusions: Our study shows that ALA-PDT and 5% IMIQ cream are bothattractive treatment
`options for upper extremities AKs with comparable efficacy and cosmetic outcomes.
`
`Similar articles
`
`Interventions for actinic keratoses.
`Gupta AK, Paquet M,Villanueva E, Brintnell W.
`Cochrane Database Syst Rev. 2012 Dec 12:12(12):CD004415. doi: 10.1002/14651858.CD004415.pub2.
`PMID: 23235610
`Free PMC article.
`Review.
`
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`
`oe @
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`< Abstract
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`Sinilor-asticles
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`Cited by
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`
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`
`Related information
`
`LinkOut - more
`resources
`
`Photodynamic therapy is more effective than imiquimod for actinic keratosis in organ
`transplant recipients: a randomized intraindividual controlled trial.
`Togsverd-Bo K, Halldin C. Sandberg C, Gonzalez H, Wennberg AM, Sarensen SS, Wulf HC, Haedersdal M.
`Br J Dermatol. 2018 Apr:178(4):903-909. doi: 10.1111/bjd.15884. Epub 2018 Feb5.
`PMID: 28796885
`Clinical Trial.
`A multicenter, randomized, vehicle-controlled phase 2 study of
`therapy with aminolevulinic acid HC! 20% topical solution for thd
`karatncac an the tinner avtramitiac: the effact af accliusian durin
`
`
`
`Biofrontera Exhibit 1033
`Biofrontera Inc. et al. v. DUSA Pharmaceuticals, Inc.
`IPR2022-00056
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`001
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`

`

`2 GQ @ pubmednchinimnih.gov/19470041/
`
`NIH) National Library of Medicine
`
`National Center for BiotechnologyInformation
`
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`
`=
`
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`
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`
`User Guide
`
`Advanced
`
`
`| | Save | Email | Send to | Display options
`
`
`
`
`
`
`
`
`
`Randomized Controlled Trial
`> J Eur Acad Dermatol Venereol. 2009 Sep;23(9):1061-5.
`FULL TEXT LINKS
`
`doi: 10.1111/j.1468-3083.2009.03259.x. Epub 2009 Apr8.lWwiteyBee
`
`Intraindividual, right-left comparison of topical 5-
`aminolevulinic acid photodynamic therapy vs. 5%
`imiquimod cream for actinic keratoses on the upper
`extremities
`
`iii
`
`
`
`E Sotiriou ', 7 Apalla, F Maliamani, N Zaparas, D Panagiotidou, D loannides
`Affiliations + expand
`PMID: 19470041 DOI: 10.1111/).1468-3083.2009.03259.x
`
`Abstract
`
`Background: Actinic keratoses (AKs) are considered as in situ squamous cell carcinoma. Early and
`effective treatmentis important. Objective To compare the efficacy, cosmetic outcome and patient
`preference of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) with that of 5% imiquimod
`(IMIQ) cream in patients with AKs on the dorsa of hands and forearms.
`Methods: Subjects received two ALA-PDTtreatment sessions and one or two courses of imiquimod
`(three times per week for 4 weeks each). Treatments were randomly allocated to alternate upper
`extremities. Assessments included lesion response one and six monthsafter treatment, cosmetic
`outcome evaluated by the investigators and patients’ preference 6 months after treatment. Efficacy
`end point included the individual AK lesion clearance rate.
`
`Results: Thirty patients with 256 lesions were included in the study. At the first follow-up, treatment
`with ALA-PDTresulted in significantly larger rate of cured lesionsrelative to 5% IMIQ cream (70.16%
`vs. 18.2696). At the second follow-up both treatments showed a high rate of cured lesions (65.32% for
`PDTvs. 55.65% for IMIQ cream). Response rates obtained in grade | lesions were higher for both
`treatments (71.64% for PDT vs. 72.13% for IMIQ), while treatment with PDT resultedin a significant
`larger rate of cured gradeII lesions (57.89% for PDT vs. 37.03 for IMIQ). Difference in cosmetic
`outcome was notstatistically significant. Results for subject preference favoured ALA-PDT.
`
`Conclusions: Our study shows that ALA-PDT and 5% IMIQ cream are bothattractive treatment
`options for upper extremities AKs with comparable efficacy and cosmetic outcomes.
`
`Similar articles
`
`Interventions foractinic keratoses.
`Gupta AK, Paquet M,Villanueva E, Brintnell W.
`Cochrane Database Syst Rev. 2012 Dec 12:12(12):CD004415. doi: 10.1002/14651858.CD004415.pub2.
`PMID: 23235610
`Free PMC article.
`Review.
`
`Photodynamic therapy is more effective than imiquimod for actinic keratosis in organ
`transplant recipients: a randomized intraindividual controlled trial.
`Togsverd-Bo K, Halldin C. Sandberg C, Gonzalez H, Wennberg AM, Sarensen SS, Wulf HC, Haedersdal M.
`Br J Dermatol. 2018 Apr:178(4):903-909. doi: 10.1111/bjd.15884. Epub 2018 Feb 5.
`PMID: 28796885
`Clinical Trial.
`
`A multicenter, randomized, vehicle-controlled phase 2 study of blue light photodynamic
`therapy with aminolevulinic acid HCl 20% topical solution for the treatment of actinic
`karatncac an the tinner avtramitiac: the effact af accliucian diurina the dria incihatinn
`
`SHARE
`
`oe @
`
`PAGE NAVIGATION
`
`Title & authors
`
`< Abstract
`
`Sinilor-asticles
`;
`Cited by
`
`Publication types
`
`MeSH terms
`
`Substances
`
`Related information
`
`LinkOut - more
`
`PesCurces
`
`001
`
`001
`
`€
`

`

`PRU UUGUUnQege Ug eee
`
`period.
`Schmieder GJ, Huang EY, Jarratt M.
`J Drugs Dermatol. 2012 Dec;11(12):1483-9.
`PMID: 23377520
`Clinical Trial.
`
`Results of an investigator-initiated single-blind split-face comparison of photodynamic
`therapy and 5% imiquimod cream for the treatment of actinic keratoses.
`Hadley J, Tristani-Firouzi P, Hull C, Florell S, Cotter M, Hadley M.
`Dermatol Surg. 2012 May;38(5):722-7. doi: 10.1111/.1524-4725.2012.02340.x. Epub 2012 Feb 16.
`PMID: 22340282
`ClinicalTrial.
`
`Current methods for photodynamic therapy in the US: comparison of MAL/PDT and
`ALA/PDT.
`Lee PK, Kloser A.
`J Drugs Dermatol. 2013 Aug:12(8):925-30.
`PMID: 23986167
`Review.
`
`Seeall similar articles
`
`Cited by5 articles
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`Ingenol mebutate in the treatmentof actinic keratoses: clearance rate and adverse effects.
`Saraiva MIR, Portocarrero LKL, Vieira MAHB, Swiczar BCC, Westin AT.
`An Bras Dermatol. 2018 Jul-Aug;93(4):529-534, doi: 10.1590/abd1806-4841.20186982.
`PMID: 30066759
`Free PMC article.
`Clinical Trial.
`
`Photodynamic Therapy and Non-Melanoma Skin Cancer.
`Griffin LL, Lear JT.
`Cancers (Basel). 2016 Oct 22;8(10):98. doi: 10.3390/cancers8100098.
`PMID: 27782094
`Free PMC article.
`Review.
`
`Comparative Study of Photodynamic Therapy with Topical Methyl Aminolevulinate versus
`5-Aminolevulinic Acid for Facial Actinic Keratosis with Long-Term Follow-Up.
`Ko DY, Kim KH, Song KH.
`Ann Dermatol. 2014 Jun:26(3):321-31. doi: 10.5021/ad.2014.26.3.321. Epub 2014 Jun 12.
`PMID: 24966631—Free PMCarticle.
`
`Interventions for actinic keratoses.
`Gupta AK, Paquet M, Villanueva E, Brintnell W.
`Cochrane Database Syst Rev. 2012 Dec 12712(12):CD004415. doi: 10.1002/14651858.CD004415.pub2.
`PMID: 23235610
`Free PMC article.
`Review.
`
`Nonsurgical innovations in the treatment of nonmelanoma skin cancer.
`Amini 5, Viera MH, Valins W, Berman B.
`J Clin Aesthet Dermatol. 2010 Jun;3(6):20-34.
`PMID: 20725548
`Free PMCarticle.
`
`Publication types
`>» Randomized Controlled Trial
`
`MeSH terms
`
`> Administration, Topical
`> Aged
`> Aminolevulinic Acid / administration & dosage
`> Aminolevulinic Acid / adverse effects
`? Aminolevulinic Acid / therapeutic use*
`> Aminoquinolines / administration & dosage
`> Aminoquinolines / adverse effects
`> Aminoquinolines / therapeutic use*
`> Dose-Response Relationship, Drug
`> Female
`> Humans
`
`> Imiquimod
`> Interferon Inducers / administration & dosage
`> Interferon Inducers / adverse effects
`> Interferon Inducers / therapeutic use*
`> Keratosis, Actinic / drug therapy”
`
`002
`
`002
`
`

`

`> Male
`
`> Middle Aged
`> Ointments
`> Patient Satisfaction
`
`> Photochemotherapy / methods*
`> Photosensitizing Agents / administration & dosage
`> Photosensitizing Agents / adverse effects
`> Photosensitizing Agents / therapeutic use*
`> Treatment Outcome
`
`> Upper Extremity
`
`Substances
`
`> Aminoquinolines
`> Interferon Inducers
`> Ointments
`
`> Photosensitizing Agents
`> Aminolevulinic Acid
`
`> Imiquimod
`
`Related information
`
`MedGen
`
`PubChem Compound
`PubChem Compound (MeSH Keyword)
`PubChem Substance
`
`LinkOut - more resources
`Full Text Sources
`
`Ovid Technologies,Inc.
`Wiley
`OtherLiterature Sources
`The Lens - Patent Citations
`
`Medical
`
`ClinicalTrials.gov
`
`NCBI Literature Resources MeSH
`
`PMC
`
`Bookshelf
`
`Disclaimer
`
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