NCT03805737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

January 14, 2019

Last Update Submit

January 19, 2022

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, immediately post-procedure (2 hours) and one and 6 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.

    Baseline and immediately post procedure

Study Arms (2)

Indoor Daylight PDT Therapy

EXPERIMENTAL

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.

Other: Amulez and sunlight

FDA Approved Standard Light Therapy Treatment

ACTIVE COMPARATOR

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.

Other: Amulez and red light treatment

Interventions

Amulez and sunlightOTHER

Amulez and sun exposure for 2 hours

Indoor Daylight PDT Therapy
Amulez and red light treatmentOTHER

Amulez and red light treatment for 10 minutes

FDA Approved Standard Light Therapy Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (10)

  • 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.

    PMID: 21080805BACKGROUND

  • 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.

    PMID: 22211665BACKGROUND

  • Griffin LL, Lear JT. Photodynamic Therapy and Non-Melanoma Skin Cancer. Cancers (Basel). 2016 Oct 22;8(10):98. doi: 10.3390/cancers8100098.

    PMID: 27782094BACKGROUND

  • 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.

    PMID: 22688660BACKGROUND

  • 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.

    PMID: 21564050BACKGROUND

  • 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.

    PMID: 25997508BACKGROUND

  • 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.

    PMID: 24996661BACKGROUND

  • 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.

    PMID: 26480810BACKGROUND

  • 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.

    PMID: 18301577BACKGROUND

  • 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.

    PMID: 37538332DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Sunlight

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, NonionizingWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Michael Shane Chapman, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physican

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 16, 2019

Study Start

November 1, 2019

Primary Completion

October 6, 2021

Study Completion

October 6, 2021

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)