Photographing the Skin During Photodynamic Therapy

NCT ID: NCT03167762

Last Updated: 2021-07-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2021-06-01

Brief Summary

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Photodynamic therapy (PDT) is used to treat some types of sun-damaged skin and low-grade forms of growths. A cream is applied to the skin, and the chemical in this cream is absorbed in to the skin and converted in to a 'photosensitiser'. This photosensitiser is fluorescent, meaning that it produces red light when blue light is shone on it. By measuring how much light is given off with a camera, the investigators can determine how much photosensitiser is present in the skin. Also, it is thought that more of the chemical is converted to the active photosensitiser if the skin is warmer, so the investigators plan to measure the temperature of the skin using a thermal camera. Light is shone on to the skin and this activates the photosensitiser, treating the problem area and leaving healthy skin intact. This research will increase the investigators understanding of how PDT works, and may help the investigators to improve treatment regimens so that they can be made more effective and better tolerated

Detailed Description

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Conditions

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Basal Cell Carcinoma Bowen's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Study group

Group Type EXPERIMENTAL

Fluorescence and thermal imaging

Intervention Type DEVICE

Two cameras used to take images of the skin. One, to measure the fluorescence from the photosensitiser, and the second to measure the surface temperature of the skin

Interventions

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Fluorescence and thermal imaging

Two cameras used to take images of the skin. One, to measure the fluorescence from the photosensitiser, and the second to measure the surface temperature of the skin

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients presenting with superficial BCC or Bowen's disease (one or two lesions and diagnosed either clinically or histologically and untreated or having had no treatment for 4 months or longer) 2. Adult males and females, \>18 years only 3. Capable of giving informed consent 4. Able to understand and adhere to protocol requirements

Exclusion Criteria

* 1\. Patients skin lesions have had previous treatment in the last 4 months 2. Unable to give informed consent 3. Known allergy to Metvix® 4. Known to have a light sensitive disorder 5. Pregnant, breastfeeding or planning to conceive
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ninewells Hopsital

Dundee, Tayside, United Kingdom

Site Status

Countries

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United Kingdom

References

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Morton CA, McKenna KE, Rhodes LE; British Association of Dermatologists Therapy Guidelines and Audit Subcommittee and the British Photodermatology Group. Guidelines for topical photodynamic therapy: update. Br J Dermatol. 2008 Dec;159(6):1245-66. doi: 10.1111/j.1365-2133.2008.08882.x. Epub 2008 Oct 13.

Reference Type BACKGROUND
PMID: 18945319 (View on PubMed)

Morton CA, Szeimies RM, Sidoroff A, Braathen LR. European guidelines for topical photodynamic therapy part 1: treatment delivery and current indications - actinic keratoses, Bowen's disease, basal cell carcinoma. J Eur Acad Dermatol Venereol. 2013 May;27(5):536-44. doi: 10.1111/jdv.12031. Epub 2012 Nov 26.

Reference Type BACKGROUND
PMID: 23181594 (View on PubMed)

Valentine RM, Ibbotson SH, Wood K, Brown CT, Moseley H. Modelling fluorescence in clinical photodynamic therapy. Photochem Photobiol Sci. 2013 Jan;12(1):203-13. doi: 10.1039/c2pp25271f.

Reference Type BACKGROUND
PMID: 23128146 (View on PubMed)

Mamalis A, Koo E, Sckisel GD, Siegel DM, Jagdeo J. Temperature-dependent impact of thermal aminolaevulinic acid photodynamic therapy on apoptosis and reactive oxygen species generation in human dermal fibroblasts. Br J Dermatol. 2016 Sep;175(3):512-9. doi: 10.1111/bjd.14509. Epub 2016 Jul 24.

Reference Type BACKGROUND
PMID: 26931503 (View on PubMed)

Kulyk O, Ibbotson SH, Moseley H, Valentine RM, Samuel ID. Development of a handheld fluorescence imaging device to investigate the characteristics of protoporphyrin IX fluorescence in healthy and diseased skin. Photodiagnosis Photodyn Ther. 2015 Dec;12(4):630-9. doi: 10.1016/j.pdpdt.2015.10.002. Epub 2015 Oct 20.

Reference Type RESULT
PMID: 26467274 (View on PubMed)

Other Identifiers

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17/WS/0055

Identifier Type: -

Identifier Source: org_study_id

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