Trial Outcomes & Findings for Randomized Comparison of Low and Conventional Irradiance PDT for Skin Cancer (NCT NCT02872909)

NCT ID: NCT02872909

Last Updated: 2019-01-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

one week after treatment

Results posted on

2019-01-04

Participant Flow

Participant milestones

Participant milestones
Measure
Low Irradiance LED PDT
Ambulight LED portable PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Conventional Higher Irradiance LED
Conventional LED hospital based standard PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Overall Study
STARTED
32
18
Overall Study
COMPLETED
32
18
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Low Irradiance LED PDT
n=32 Participants
Ambulight LED portable PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Conventional Higher Irradiance LED
n=18 Participants
Conventional LED hospital based standard PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Total
n=50 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=32 Participants
0 Participants
n=18 Participants
0 Participants
n=50 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=32 Participants
2 Participants
n=18 Participants
12 Participants
n=50 Participants
Age, Categorical
>=65 years
22 Participants
n=32 Participants
16 Participants
n=18 Participants
38 Participants
n=50 Participants
Age, Continuous
75 years
n=32 Participants
71 years
n=18 Participants
71 years
n=50 Participants
Sex: Female, Male
Female
23 Participants
n=32 Participants
12 Participants
n=18 Participants
35 Participants
n=50 Participants
Sex: Female, Male
Male
9 Participants
n=32 Participants
6 Participants
n=18 Participants
15 Participants
n=50 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United Kingdom
34 participants
n=32 Participants
18 participants
n=18 Participants
52 participants
n=50 Participants

PRIMARY outcome

Timeframe: one week after treatment

Population: The ambulatory devices suffered technical failure in the first two participants so no data were available for these subjects. Data were available for 32 participants treated with ambulatory PDT and 18 treated with conventional PDT

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

Outcome measures

Outcome measures
Measure
Low Irradiance LED PDT
n=32 Participants
Ambulight LED portable PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Conventional Higher Irradiance LED
n=18 Participants
Conventional LED hospital based standard PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Pain on VAS Score
2.95 score on a scale
Interval 0.5 to 4.8
1.25 score on a scale
Interval 0.7 to 2.8

SECONDARY outcome

Timeframe: one week after treatment

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)

Outcome measures

Outcome measures
Measure
Low Irradiance LED PDT
n=32 Participants
Ambulight LED portable PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Conventional Higher Irradiance LED
n=18 Participants
Conventional LED hospital based standard PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Phototoxicity
2 score on a scale
Interval 0.0 to 3.0
1 score on a scale
Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 12 months after treatment

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

Outcome measures

Outcome measures
Measure
Low Irradiance LED PDT
n=32 Participants
Ambulight LED portable PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Conventional Higher Irradiance LED
n=18 Participants
Conventional LED hospital based standard PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Clinical Clearance of Lesion
27 Participants
14 Participants

SECONDARY outcome

Timeframe: one year after treatment - last visit

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

Outcome measures

Outcome measures
Measure
Low Irradiance LED PDT
n=32 Participants
Ambulight LED portable PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Conventional Higher Irradiance LED
n=18 Participants
Conventional LED hospital based standard PDT treatment Ambulight (Ambicare Health): battery-operated low irradiance red light LED ("skin cancer plaster")
Patient Satisfaction
10 score on a scale
Interval 5.5 to 10.0
10 score on a scale
Interval 8.0 to 10.0

Adverse Events

Low Irradiance LED PDT

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Conventional Higher Irradiance LED

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Sally Ibbotson

University of Dundee

Phone: 01382 383499

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place