Clinical trial NCT03805737: Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis
Official title: Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratosis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Norris Cotton Cancer Center
First posted: 2019-01-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand better if indoor daylight Photo Dynamic Therapy (PDT) can provide effective lesion clearing versus conventional red lamp light therapy.

Detailed description: Subjects who enroll into this research study, their participation in this study will last up to 6 months. They will be asked to return to the clinic 3-4 times.

Subjects will be randomized into one of two study arms:

Arm 1 - Indoor Daylight PDT Therapy Arm 2 - FDA Approved Standard Light Therapy Treatment

Eligibility criteria: Inclusion Criteria:

* All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment.
* Age ≥ 18 years older.

Exclusion Criteria:

* Pregnant women or women who are breast-feeding.
* Any patients with a condition that makes them not suitable for clinical PDT.

Primary outcomes:
measure: Changes or clearing of the lesions
timeFrame: Baseline, immediately post-procedure (2 hours) and one and 6 months
measure: Change in the amount of PpIX in the lesion
timeFrame: Baseline and immediately post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Michael Shane Chapman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
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