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
COMPLETED
NA
50 participants
one week after treatment
2019-01-04
Participant Flow
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
| 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 treatmentPopulation: 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
| 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 treatmenterythema, 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
| 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 treatmentclinical 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
| 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 visitbrief 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
| 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
Conventional Higher Irradiance LED
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place