Photographing the Skin During Photodynamic Therapy

NCT03167762 | Completed

• 1 other identifier: 17/WS/0055
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Basal Cell Carcinoma; Bowen's Disease

Outcome Measures

Primary Outcomes (1)

• Is there a correlation between body site temperature and degree of fluorescence prior to and/or during PDT

  Body site temperature is measured before and during PDT (in degrees Celsius) as is fluorescence signal (in arbitrary fluorescence units). These are compared for each time point in the treatment for each patient.

  12months

Secondary Outcomes (4)

• Is there a correlation between temperature and/or fluorescence and treatment outcome

  12months

• How does the spatial distribution of fluorescence and temperature change prior to and during PDT

  12months

• Pain measured immediately after irradiation

  12months

• phototoxicity (inflammation) measured immediately after irradiation

  12months

Study Arms (1)

Study group

EXPERIMENTAL

Device: Fluorescence and thermal imaging

Interventions

Fluorescence and thermal imaging 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

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Ninewells Hopsital

Dundee, Tayside, dd1 9sy, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 18945319 BACKGROUND

• 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.

  PMID: 23181594 BACKGROUND

• 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.

  PMID: 23128146 BACKGROUND

• 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.

  PMID: 26931503 BACKGROUND

• 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.

  PMID: 26467274 RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell; Bowen's Disease

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 30, 2017
• Study Start: June 22, 2017
• Primary Completion: June 22, 2020
• Study Completion: June 1, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)