Randomized Comparison of Low and Conventional Irradiance PDT for Skin Cancer

NCT02872909 | Completed Results

• 1 other identifier: 2011DS04
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to examine whether the pain of topical photodynamic therapy (PDT) is significantly different when using low irradiance ambulatory light emitting diode (LED) devices compared with conventional higher irradiance hospital based LED light sources when used for superficial non-melanoma skin cancer. The investigators are also investigating the phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.

Conditions

Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Pain on VAS Score

  assess on visual analogue scale (VAS) score of 0 - 10cm, with 0 representing no pain experienced through to 10 representing the worst pain imaginable. The participant marks across a 0-10cm unmarked line where their level of pain experience is and this is measured eg. 2cm if experiencing mild pain or 8.5cm which would represent severe pain

  one week after treatment

Secondary Outcomes (3)

• Phototoxicity

  one week after treatment

• Clinical Clearance of Lesion

  12 months after treatment

• Patient Satisfaction

  one year after treatment - last visit

Study Arms (2)

low irradiance LED PDT

ACTIVE COMPARATOR

Ambulight LED portable PDT treatment

Device: Ambulight (Ambicare Health)

conventional higher irradiance LED

ACTIVE COMPARATOR

Conventional LED hospital based standard PDT treatment

Device: Ambulight (Ambicare Health)

Interventions

Ambulight (Ambicare Health) DEVICE

battery-operated low irradiance red light LED ("skin cancer plaster")

conventional higher irradiance LED; low irradiance LED PDT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Bowen's disease or superficial basal cell carcinoma referred for PDT and lesion not greater than 2.4cm diameter

You may not qualify if:

• Unable to give consent, \>2cm diameter, lesions on highly curved surfaces where ambulatory device would not adhere

Sponsors & Collaborators

• Sally Ibbotson: lead

Related Publications (4)

• Attili SK, Lesar A, McNeill A, Camacho-Lopez M, Moseley H, Ibbotson S, Samuel ID, Ferguson J. An open pilot study of ambulatory photodynamic therapy using a wearable low-irradiance organic light-emitting diode light source in the treatment of nonmelanoma skin cancer. Br J Dermatol. 2009 Jul;161(1):170-3. doi: 10.1111/j.1365-2133.2009.09096.x. Epub 2009 Mar 19.

  PMID: 19302071 BACKGROUND

• Moseley H, Allen JW, Ibbotson S, Lesar A, McNeill A, Camacho-Lopez MA, Samuel ID, Sibbett W, Ferguson J. Ambulatory photodynamic therapy: a new concept in delivering photodynamic therapy. Br J Dermatol. 2006 Apr;154(4):747-50. doi: 10.1111/j.1365-2133.2006.07145.x.

  PMID: 16536822 BACKGROUND

• Ibbotson SH. Irradiance is an important determinant of pain experienced during topical photodynamic therapy. J Am Acad Dermatol. 2011 Jul;65(1):201-2. doi: 10.1016/j.jaad.2010.11.060. No abstract available.

  PMID: 21679812 BACKGROUND

• Ibbotson SH, Ferguson J. Ambulatory photodynamic therapy using low irradiance inorganic light-emitting diodes for the treatment of non-melanoma skin cancer: an open study. Photodermatol Photoimmunol Photomed. 2012 Oct;28(5):235-9. doi: 10.1111/j.1600-0781.2012.00681.x.

  PMID: 22971187 BACKGROUND

Limitations and Caveats

Nil of note

Results Point of Contact

• Title: Professor Sally Ibbotson
• Organization: University of Dundee

s.h.ibbotson@dundee.ac.uk

01382 383499

Study Officials

• Sally H Ibbotson, MD

  University of Dundee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Sally H Ibbotson

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 19, 2016
• Study Start: October 1, 2011
• Primary Completion: February 6, 2017
• Study Completion: February 6, 2017
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: presenting study data at British Association of Dermatologists annual meeting Edinburgh 5.7.18 and abstract will be published in Br J Dermatol and full publication will follow
• Access Criteria: via presentation and publication in peer-reviewed journal