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Non-melanoma Skin CancerNCT02872909

Randomized Comparison of Low and Conventional Irradiance PDT for Skin Cancer

A study testing Ambulight (Ambicare Health) in people with Non-melanoma Skin Cancer, run by Sally Ibbotson.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Non-melanoma Skin Cancer
What is being tested?
Ambulight (Ambicare Health)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Oct 2011to 6 Feb 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: A Randomized Assessor-blinded Comparison of Low Irradiance and Conventional Irradiance Photodynamic Therapy (PDT) for Superficial Non-melanoma Skin Cancer

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.

Read the detailed description

A randomized assessor-blinded comparative study of low irradiance ambulatory LED devices with conventional hospital-based LED devices for superficial non-melanoma skin cancer. Preliminary observations suggest that low irradiance LEDs cause less pain but are as effective, so the investigators are examining this in a clinical trial of patients with lesions </= 2cm diameter of non-melanoma skin cancer (Bowen's disease and superficial basal cell carcinoma). Patients with these conditions referred to the PDT clinic will be invited to participate and if they are eligible and consent to treatment then they will be prospectively randomized to either ambulatory PDT or conventional PDT. Pain and phototoxicity scores will be recorded and clinical efficacy will be assessed up to one year after the last treatment. Computer-generated block randomization will be performed and at 90% power to detect as significant at the 5% level a mean difference in pain score of 2 in one group compared with 4 in the other, 36 patients will be needed, and as the participants will often be elderly and frail the investigators will aim for a safety margin of recruiting 50 participants to account for drop-outs. Participants will receive two treatments of either arm at a one week interval and will be assessed clinically at three months and if residual disease remains then the two treatments a week apart are repeated. Pain assessed using a visual analogue scale (VAS) score and phototoxicity on a semi-quantitative scale are recorded at 7 days when the participant returns for their second treatment. Follow up for clinical assessment is at 6 months and one year after treatment. Participants also give their opinion of treatment at one year follow up. Assessors of adverse effects and efficacy will be blinded. Data recording and analysis will be undertaken by the study statistician Dr Robert Dawe and analysis will be on an intention to treat basis using appropriate statistical tests comparing the pre-planned outcome measures, with pain as primary outcome and outcome, efficacy and patient satisfaction as secondary outcomes

Being tested
Ambulight (Ambicare Health)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambulight (Ambicare Health)Device

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

Study groups in NCT02872909
Study groupRoleWhat they receive
low irradiance LED PDTActive comparatorAmbulight LED portable PDT treatment
Receives: Device: Ambulight (Ambicare Health)
conventional higher irradiance LEDActive comparatorConventional LED hospital based standard PDT treatment
Receives: Device: Ambulight (Ambicare Health)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: one week after treatment

Secondary outcomes (3)

  1. Phototoxicity

    erythema, oedema, blistering, crusting, ulceration on semi-quantitative scale. Erythema is graded as 0 = absent, 1 = mild, 2 = moderate or 3 = severe erythema as assessed by naked eye examination. Oedema is graded as 0 = absent or 1 = present. Likewise crusting or ulceration are each graded as 0 = absent and 1 = present by naked eye examination. Data will be presented and analysed separately ie. erythema data will be presented and then separately whether oedema, crusting or ulceration are present or absent.

    ie. reporting may appear as example: erythema score 3 of range of 0-3 options; oedema score 1 (binary option of 0 or 1); crusting score 0 (binary option of 0 or 1); ulceration score 0 (binary option of 0 or 1)

    Measured: one week after treatment

  2. Clinical Clearance of Lesion

    clinical assessment by study dermatologist to determine by inspection and palpation whether the lesion is clear, partially clear or not clear - assessed at 3, 6 and 12 months after treatment, with 12 months as the final study outcome endpoint analysed

    Measured: 12 months after treatment

  3. Patient Satisfaction

    brief patient questionnaire to evaluate their opinion of the treatment they received. This is assessed as A.efficacy of treatment - 1 = not effective NR; 2 = partIally effective PR; 3 = completely effective CR; B.Side effects of treatment eg. pain and inflammation - 1 = severe; 2 = moderate; 3 = mild; 4 = none/minimal. C.Practicalities of treatment eg. ease of use, travel, time, inconvenience - 1 = very disruptive and difficult; 2 = moderately disruptive and difficult; 3 = minimally disruptive and difficult. The scores of A, B and C will be added to give an overall score with range of overall minimum score option 3 and maximum 10.

    Patients will also separately be asked to give overall evaluation on a VAS scale of 0 = treatment very poor and would not have again through to 10 = treatment excellent and I would have again - with a continuous line option from 0 - 10 to mark across, providing a separate score with range options 0 to 10

    Measured: one year after treatment - last visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2016 (estimated)
  2. Study startOct 2011
  3. Primary completion6 Feb 2017
  4. Study completion6 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02872909
Sponsor's protocol ID
2011DS04
Status last verified
Dec 2018
First submitted
5 Aug 2016
Last updated
4 Jan 2019
Data monitoring committee
No
Individual data sharing
Yes: peer reviewed publications and presentations at international and national meetings

Publications

  • 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.

    PubMed 19302071

  • 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.

    PubMed 16536822

  • 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.

    PubMed 21679812

  • 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.

    PubMed 22971187

Questions about this trial

What is this clinical trial studying?

A study testing Ambulight (Ambicare Health) in people with Non-melanoma Skin Cancer, run by Sally Ibbotson.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain on VAS Score (time frame: one week after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02872909, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.

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