Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis
NCT ID: NCT03805737
Last Updated: 2022-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2019-11-01
2021-10-06
Brief Summary
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Detailed Description
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Subjects will be randomized into one of two study arms:
Arm 1 - Indoor Daylight PDT Therapy Arm 2 - FDA Approved Standard Light Therapy Treatment
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Indoor Daylight PDT Therapy
Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will be exposed to natural sunlight through a window for 2 hours. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods.
Amulez and sunlight
Amulez and sun exposure for 2 hours
FDA Approved Standard Light Therapy Treatment
Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will receive Red Light Treatment for 10 minutes. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods.
Amulez and red light treatment
Amulez and red light treatment for 10 minutes
Interventions
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Amulez and sunlight
Amulez and sun exposure for 2 hours
Amulez and red light treatment
Amulez and red light treatment for 10 minutes
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years older.
Exclusion Criteria
* Any patients with a condition that makes them not suitable for clinical PDT.
18 Years
ALL
No
Sponsors
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Norris Cotton Cancer Center
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Michael S. Chapman
Staff Physican
Principal Investigators
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Michael Shane Chapman, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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Zhao B, He YY. Recent advances in the prevention and treatment of skin cancer using photodynamic therapy. Expert Rev Anticancer Ther. 2010 Nov;10(11):1797-809. doi: 10.1586/era.10.154.
Wiegell SR, Wulf HC, Szeimies RM, Basset-Seguin N, Bissonnette R, Gerritsen MJ, Gilaberte Y, Calzavara-Pinton P, Morton CA, Sidoroff A, Braathen LR. Daylight photodynamic therapy for actinic keratosis: an international consensus: International Society for Photodynamic Therapy in Dermatology. J Eur Acad Dermatol Venereol. 2012 Jun;26(6):673-9. doi: 10.1111/j.1468-3083.2011.04386.x. Epub 2011 Dec 23.
Griffin LL, Lear JT. Photodynamic Therapy and Non-Melanoma Skin Cancer. Cancers (Basel). 2016 Oct 22;8(10):98. doi: 10.3390/cancers8100098.
Zhao SG, Chen XF, Wang LG, Yang G, Han DY, Teng L, Yang MC, Wang DY, Shi C, Liu YH, Zheng BJ, Shi CB, Gao X, Rainov NG. Increased expression of ABCB6 enhances protoporphyrin IX accumulation and photodynamic effect in human glioma. Ann Surg Oncol. 2013 Dec;20(13):4379-88. doi: 10.1245/s10434-011-2201-6. Epub 2012 Jun 12.
Tyrrell JS, Morton C, Campbell SM, Curnow A. Comparison of protoporphyrin IX accumulation and destruction during methylaminolevulinate photodynamic therapy of skin tumours located at acral and nonacral sites. Br J Dermatol. 2011 Jun;164(6):1362-8. doi: 10.1111/j.1365-2133.2011.10265.x. Epub 2011 May 13.
Nissen CV, Philipsen PA, Wulf HC. Protoporphyrin IX formation after topical application of methyl aminolaevulinate and BF-200 aminolaevulinic acid declines with age. Br J Dermatol. 2015 Sep;173(3):760-6. doi: 10.1111/bjd.13923. Epub 2015 Aug 20.
Kanick SC, Davis SC, Zhao Y, Hasan T, Maytin EV, Pogue BW, Chapman MS. Dual-channel red/blue fluorescence dosimetry with broadband reflectance spectroscopic correction measures protoporphyrin IX production during photodynamic therapy of actinic keratosis. J Biomed Opt. 2014;19(7):75002. doi: 10.1117/1.JBO.19.7.075002.
Kanick SC, Davis SC, Zhao Y, Sheehan KL, Hasan T, Maytin EV, Pogue BW, Chapman MS. Pre-treatment protoporphyrin IX concentration in actinic keratosis lesions may be a predictive biomarker of response to aminolevulinic-acid based photodynamic therapy. Photodiagnosis Photodyn Ther. 2015 Dec;12(4):561-6. doi: 10.1016/j.pdpdt.2015.10.006. Epub 2015 Oct 22.
Pogue BW, Burke G. Fiber-optic bundle design for quantitative fluorescence measurement from tissue. Appl Opt. 1998 Nov 1;37(31):7429-36. doi: 10.1364/ao.37.007429.
Ruiz AJ, LaRochelle EPM, Fahrner MP, Emond JA, Samkoe KS, Pogue BW, Chapman MS. Equivalent efficacy of indoor daylight and lamp-based 5-aminolevulinic acid photodynamic therapy for treatment of actinic keratosis. Skin Health Dis. 2023 Mar 31;3(4):e226. doi: 10.1002/ski2.226. eCollection 2023 Aug.
Other Identifiers
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D19030
Identifier Type: -
Identifier Source: org_study_id
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