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`> Dermatol Surg. 2014 Oct;40(10):1094-102. doi: 10.1097/01.DSS$.0000452662.69539.57.
`
`Temperature-modulated photodynamic therapyfor
`the treatmentof actinic keratosis on the extremities:
`
`a pilot study
`
`Andrea Willey |, R Rox Anderson, Fernanda H Sakamoto
`
`Affiliations ++ expand
`PMID: 25207759 DOI: 10.1097/01.DSS,0000452662.69539.57
`Abstract
`Background: The efficacy of photodynamic therapy (PDT) using topical 5-aminolevulinic acid (ALA)
`for the treatment of actinic keratosis (AKs) is lower on the distal extremities compared with the head
`and neck areas. The strong temperature dependence ofporphyrin synthesis in biologic tissue
`suggests that heating skin during incubation may improve the efficacy of PDT, particularly in areas
`where biologic temperatures are naturally lower. The aim of this study was to evaluate the efficacy
`and tolerability of temperature-modulated PDT for the treatment of AKs on the extremities.
`
`Methods: In this [RB-approved, single-center study, the upper or lower extremities of 20 subjects
`were treated with 20% ALA under occlusion, followed by 10 J/cm, 417-nm blue light. One of the 2
`extremities treated was heated during the 1-hour incubation. Outcome measuresincluded lesion
`counts, tolerability, and global improvementat baseline, 1 week, and 2 and 6 monthsafter treatment.
`
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`Results: The median temperatures of the heated and control sides were 38.8°C and 29.4°C,
`respectively. The median clearance for the heated side wassignificantly greater than the control side
`at 2 and 6 months(p < .0001). Typical PDT side effects were greater on the heated side compared
`with the control yet were well tolerated by all subjects.
`.
`.
`.
`.
`. . .
`Conclusion: Warming the skin during incubation of ALA seems to improve the efficacy of PDT in the
`treatment of AKs on the extremities and is well tolerated when heat application is controlled within
`LinkOut -
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`Temperature-Modulated Photodynamic Therapy for the Treatment of Actinic Keratosis on
`the Extremities: A One-Year Follow-up Study.
`Willey A, Anderson RR, Sakamoto FH.
`Dermatol Surg. 2015 Nov;41(11):1290-5. doi: 10.1097/DSS.0000000000000512.
`PMID: 26445287
`
`A multicenter, randomized, vehicle-controlled phase 2 study of blue light photodynamic
`therapy with aminolevulinic acid HCl 20% topical solution for the treatmentof actinic
`keratoses on the upper extremities: the effect of occlusion during the drug incubation
`period.
`Schmieder GJ, Huang EY,Jarratt M.
`J Drugs Dermatol. 2012 Dec11(12):1483-9.
`PMID: 23377520
`Clinical Trial.
`
`A randomized, blinded,bilateral intraindividual, vehicle-controll
`photodynamic therapy with 5-aminolevulinic acid and blue ligh
`actinic keratoses of the upper extremities.
`Taub AF, Garretson CB.
`
`Biofrontera Exhibit 1032
`Biofrontera Inc. et al. v. DUSA Pharmaceuticals, Inc.
`
`| PR202 2-00056
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`001
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`ect
`
`@ pubmed.ncbi.nim.nih.gov/25207759/
`
`NIH) National Library of Medicine
`
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`PubWed.co
`
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`
`Advanced
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`User Guide
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`Send to
`Display options
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`
`> Dermatol Surg. 2014 Oct;40(10):1094-102. doi: 10.1097/01.DSS$.0000452662.69539.57.
`
`Temperature-modulated photodynamic therapyfor
`the treatmentof actinic keratosis on the extremities:
`a pilot study
`
`Andrea Willey |, R Rox Anderson, Fernanda H Sakamoto
`
`Affiliations ++ expand
`PMID: 25207759 DOI: 10.1097/01.DSS.0000452662.69539,.57
`
`Abstract
`
`Background: The efficacy of photodynamic therapy (PDT) using topical 5-aminolevulinic acid (ALA)
`for the treatment of actinic keratosis (AKs) is lower on the distal extremities compared with the head
`and neck areas. The strong temperature dependence ofporphyrin synthesis in biologic tissue
`suggests that heating skin during incubation may improve the efficacy of PDT, particularly in areas
`where biologic temperatures are naturally lower. The aim of this study was to evaluate the efficacy
`and tolerability of temperature-modulated PDT for the treatment of AKs on the extremities.
`
`Methods: In this [RB-approved, single-center study, the upper or lower extremities of 20 subjects
`were treated with 20% ALA under occlusion, followed by 10 J/cm, 417-nm blue light. One of the 2
`extremities treated was heated during the 1-hour incubation. Outcome measuresincluded lesion
`counts, tolerability, and global improvementat baseline, 1 week, and 2 and 6 monthsafter treatment.
`
`Results: The median temperatures of the heated and control sides were 38.8°C and 29.4°C,
`respectively. The median clearance for the heated side wassignificantly greater than the control side
`at 2 and 6 months(p < .0001). Typical PDT side effects were greater on the heated side compared
`with the control yet were well tolerated by all subjects.
`
`Conclusion: Warming the skin during incubation of ALA seems to improve the efficacy of PDT in the
`treatment of AKs on the extremities and is well tolerated when heat application is controlled within
`the limits of safety.
`
`Similar articles
`
`Temperature-Modulated Photodynamic Therapy for the Treatment of Actinic Keratosis on
`the Extremities: A One-Year Follow-up Study.
`Willey A, Anderson RR, Sakamoto FH.
`Dermatol Surg. 2015 Nov;41(11):1290-5. doi: 10.1097/DSS.0000000000000512.
`PMID: 26445287
`
`A multicenter, randomized, vehicle-controlled phase 2 study of blue light photodynamic
`therapy with aminolevulinic acid HCl 20% topical solution for the treatmentof actinic
`keratoses on the upper extremities: the effect of occlusion during the drug incubation
`period.
`Schmieder GJ, Huang EY,Jarratt M.
`J Drugs Dermatol. 2012 Dec11(12):1483-9.
`PMID: 23377520
`Clinical Trial.
`
`A randomized, blinded,bilateral intraindividual, vehicle-controlled trial of the use of
`photodynamic therapy with 5-aminolevulinic acid and blue light for the treatment of
`actinic keratoses of the upper extremities.
`Taub AF, Garretson CB.
`
`FULL TEXT LINKS
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`J Drugs Dermatol. 2011 Sep; 10(9):1049-56,
`PMID: 22052276
`Clinical Trial.
`
`Spanish-Portuguese consensus statement on use of daylight-mediated photodynamic
`therapy with methyl aminolevulinate in the treatment of actinic keratosis.
`Gilaberte ¥, Aguilar M. Almagro M, Correia O, Guillén C, Harto A, Pérez-Garcia B, Pérez-Pérez L, Redondo P, Sanchez-
`Carpintero |, Serra-Guillén C, Valladares LM.
`Actas Dermosifiliogr. 2015 Oct;106(8):623-31. doi: 10.1016/).ad.2015.06.001. Epub 2015 Jun 24.
`PMID: 26115793
`English, Spanish.
`
`Current treatments of actinic keratosis.
`Gold MH, Nestor MS.
`J Drugs Dermatol. 2006 Feb;5(2 Suppl):17-25.
`PMID: 16485877
`Review.
`
`See all similar articles
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`Cited by8 articles
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`Comparison of Blue and White Lamp Light with Sunlight for Daylight-Mediated, 5-ALA
`Photodynamic Therapy, in vivo.
`Marra K, LaRochelle EP, Chapman MS, Hoopes PJ, Lukovits K, Maytin EV, Hasan T, Pogue BW.
`Photochem Photobiol. 2018 Sep;94(5):1049-1057. doi: 10.1111/php.12923. Epub 2018 May 16.
`PMID: 29663426
`Free PMC article.
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`ALA-PplX mediated photodynamic therapy of malignant gliomas augmented by
`hypothermia.
`Fisher CJ, Niu C, Foltz W, Chen Y, Sidorova-Darmos E, Eubanks JH,Lilge L.
`PLoS One. 2017 Jul 31;12(7):e0181654. doi: 10.1371/journal.pone.0181654. eCollection 2017.
`PMID: 28759636
`Free PMCarticle.
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`Photodynamic therapy in dermatology beyond non-melanoma cancer: An update.
`Wen X, Li ¥, Hamblin MR.
`Photodiagnosis Photodyn Ther. 2017 Sep;19:140-152. doi: 10.1016/j.pdpdt.2017.06.010. Epub 2017 Jun 21.
`PMID: 28647616
`Free PMC article.
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`Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of
`Actinic Keratoses: A Randomized Clinical Trial.
`Petukhova TA, HassounLA, Foolad N, Barath M, Sivamani RK.
`JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.201 7.0849,
`PMID: 28514458
`Free PMC article.
`Clinical Trial.
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`Current Advances in 5-Aminolevulinic Acid Mediated Photodynamic Therapy.
`Thunshelle C, Yin R, Chen Q, Hamblin MR.
`Curr Dermatol Rep. 2016 Sep;5(3):179-190. doi: 10.1007/s13671-016-0154-5. Epub 2016 Jul 13.
`PMID: 28163981
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`See all "Cited by"articles
`
`MeSH terms
`
`> Aged
`> Aged, 80 and over
`> Aminolevulinic Acid / therapeutic use*
`> Blister / etiology
`> Clinical Protocols
`
`> Erythema/ etiology
`> Extremities
`> Female
`> Humans
`
`> Keratosis, Actinic / drug therapy*
`> Male
`
`> Middle Aged
`> Pain / etiology
`> Photochemotherapy / adverse effects
`> Photochemotherapy / methods*
`> Photosensitizing Agents / therapeutic use*
`> Pilat Projects
`> Skin Temperature
`> Temperature
`
`002
`
`002
`
`
`
`> Treatment Outcome
`
`Substances
`
`> Photosensitizing Agents
`> Aminolevulinic Acid
`
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