Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

Overview

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.

Full Title of Study: “Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2020

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

Interventions

  • Other: Amulez and sunlight
    • Amulez and sun exposure for 2 hours
  • Other: Amulez and red light treatment
    • Amulez and red light treatment for 10 minutes

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Changes or clearing of the lesions
    • Time Frame: Baseline, immediately post-procedure (2 hours) and one and 6 months
    • The primary aim of this study is to study if indoor daylight PDT can be as effective as regular lamp light PDT. This study can be confounded by the amount of PpIX produced in the lesions as well as the clearing of lesions at one month and six months.
  • Change in the amount of PpIX in the lesion
    • Time Frame: Baseline and immediately post procedure
    • Secondary diagnostic study to determine if low-cost cellphone-based skin dosimetry in PDT can facilitate objective measurement of drug levels.

Participating in This Clinical Trial

Inclusion Criteria

  • All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment.
  • Age ≥ 18 years old and ≤ 75 years old.

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dartmouth-Hitchcock Medical Center
  • Collaborator
    • Norris Cotton Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael S. Chapman, Staff Physican – Dartmouth-Hitchcock Medical Center
  • Overall Official(s)
    • Michael Shane Chapman, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center
  • Overall Contact(s)
    • Debra J Rodgers, 603-650-3693, Debra.J.Rodgers@Hitchcock.org

References

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. Review.

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. Review.

Griffin LL, Lear JT. Photodynamic Therapy and Non-Melanoma Skin Cancer. Cancers (Basel). 2016 Oct 22;8(10). pii: E98. Review.

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.

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