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Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amulez and sunlight
Amulez and red light treatment
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dartmouth Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indoor Daylight PDT Therapy

FDA Approved Standard Light Therapy Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes or clearing of the lesions
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
Secondary diagnostic study to determine if low-cost cellphone-based skin dosimetry in PDT can facilitate objective measurement of drug levels.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2019
Last Updated
January 19, 2022
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Norris Cotton Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03805737
Brief Title
Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis
Official Title
Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 6, 2021 (Actual)
Study Completion Date
October 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Norris Cotton Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indoor Daylight PDT Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
FDA Approved Standard Light Therapy Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Amulez and sunlight
Intervention Description
Amulez and sun exposure for 2 hours
Intervention Type
Other
Intervention Name(s)
Amulez and red light treatment
Intervention Description
Amulez and red light treatment for 10 minutes
Primary Outcome Measure Information:
Title
Changes or clearing of the lesions
Description
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.
Time Frame
Baseline, immediately post-procedure (2 hours) and one and 6 months
Title
Change in the amount of PpIX in the lesion
Description
Secondary diagnostic study to determine if low-cost cellphone-based skin dosimetry in PDT can facilitate objective measurement of drug levels.
Time Frame
Baseline and immediately post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Shane Chapman, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21080805
Citation
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.
Results Reference
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PubMed Identifier
22211665
Citation
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.
Results Reference
background
PubMed Identifier
27782094
Citation
Griffin LL, Lear JT. Photodynamic Therapy and Non-Melanoma Skin Cancer. Cancers (Basel). 2016 Oct 22;8(10):98. doi: 10.3390/cancers8100098.
Results Reference
background
PubMed Identifier
22688660
Citation
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.
Results Reference
background
PubMed Identifier
21564050
Citation
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.
Results Reference
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PubMed Identifier
25997508
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.
Results Reference
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PubMed Identifier
24996661
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.
Results Reference
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PubMed Identifier
26480810
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.
Results Reference
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PubMed Identifier
18301577
Citation
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.
Results Reference
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Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

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