Trial Outcomes & Findings for Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses (NCT NCT01821391)
NCT ID: NCT01821391
Last Updated: 2021-02-18
Results Overview
The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
Group 1
Participants applied single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix cream topically followed by c- PDT (active comparator) on Day 0 (Baseline).
|
Group 2
Participants applied a single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix vehicle cream (placebo) followed by c-PDT on Day 0 (Baseline).
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
23
|
|
Overall Study
COMPLETED
|
107
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1
Participants applied single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix cream topically followed by c- PDT (active comparator) on Day 0 (Baseline).
|
Group 2
Participants applied a single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix vehicle cream (placebo) followed by c-PDT on Day 0 (Baseline).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
Baseline characteristics by cohort
| Measure |
Group 1
n=108 Participants
Participants applied single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix cream topically followed by c- PDT (active comparator) on Day 0 (Baseline).
|
Group 2
n=23 Participants
Participants applied a single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix vehicle cream (placebo) followed by c-PDT on Day 0 (Baseline).
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
19 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
Age · >=65 years
|
89 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race
White
|
108 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Phototype
Phototype I
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Phototype
Phototype II
|
69 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Phototype
Phototype III
|
24 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Phototype
Phototype IV
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Duration of AK (years)
|
9.66 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
6.79 years
STANDARD_DEVIATION 5.81 • n=7 Participants
|
9.15 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat (ITT) population included entire population enrolled and randomized. ITT analysis imputed missing data using a worst case approach and considered the lesions with missed lesion response assessment as not responded (ITT/Worst-case) lesions.
The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I).
Outcome measures
| Measure |
Group I: Metvix NDL-PDT
n=108 Participants
Participants applied topically a single dose of Metvix cream followed by NDL-PDT on Day 0 (Baseline).
|
Group I: Metvix c-PDT
n=108 Participants
Participants applied topically a single dose of Metvix cream followed by C-PDT on Day 0 (Baseline).
|
|---|---|---|
|
Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1
|
68.4 percentage change from baseline
Standard Deviation 27.7
|
71.5 percentage change from baseline
Standard Deviation 27.6
|
Adverse Events
NDL-PDT
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
c-PDT
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Placebo c-PDT
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Unspecific Treated Side
Serious events: 6 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
NDL-PDT
n=131 participants at risk
Metvix natural daylight photodynamic therapy treated side
|
c-PDT
n=108 participants at risk
Metvix conventional photodynamic therapy treated side
|
Placebo c-PDT
n=23 participants at risk
Placebo conventional photodynamic therapy treated side
|
Unspecific Treated Side
n=131 participants at risk
AE occuring outside the treated area + systemic AE
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA/ SUPPOSED WATER IN LUNG
|
0.00%
0/131 • 3 months
|
0.00%
0/108 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/131 • 3 months
|
0.00%
0/108 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasia
|
0.00%
0/131 • 3 months
|
0.00%
0/108 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/131 • 3 months
|
0.00%
0/108 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/131 • 3 months
|
0.00%
0/108 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Mallory weiss lesion in oesophagus
|
0.00%
0/131 • 3 months
|
0.00%
0/108 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/131 • 3 months
|
0.00%
0/108 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
NDL-PDT
n=131 participants at risk
Metvix natural daylight photodynamic therapy treated side
|
c-PDT
n=108 participants at risk
Metvix conventional photodynamic therapy treated side
|
Placebo c-PDT
n=23 participants at risk
Placebo conventional photodynamic therapy treated side
|
Unspecific Treated Side
n=131 participants at risk
AE occuring outside the treated area + systemic AE
|
|---|---|---|---|---|
|
Infections and infestations
Rash pustular
|
0.76%
1/131 • Number of events 1 • 3 months
|
1.9%
2/108 • Number of events 2 • 3 months
|
0.00%
0/23 • 3 months
|
0.00%
0/131 • 3 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrage
|
3.8%
5/131 • Number of events 5 • 3 months
|
3.7%
4/108 • Number of events 4 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/131 • 3 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.5%
2/131 • Number of events 2 • 3 months
|
0.93%
1/108 • Number of events 1 • 3 months
|
0.00%
0/23 • 3 months
|
0.00%
0/131 • 3 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
23.7%
31/131 • Number of events 31 • 3 months
|
36.1%
39/108 • Number of events 39 • 3 months
|
17.4%
4/23 • Number of events 4 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.1%
8/131 • Number of events 8 • 3 months
|
10.2%
11/108 • Number of events 11 • 3 months
|
0.00%
0/23 • 3 months
|
0.00%
0/131 • 3 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
7.6%
10/131 • Number of events 10 • 3 months
|
7.4%
8/108 • Number of events 8 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/131 • 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.9%
13/131 • Number of events 13 • 3 months
|
14.8%
16/108 • Number of events 16 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Scab
|
9.2%
12/131 • Number of events 12 • 3 months
|
14.8%
16/108 • Number of events 17 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
9.2%
12/131 • Number of events 12 • 3 months
|
14.8%
16/108 • Number of events 17 • 3 months
|
0.00%
0/23 • 3 months
|
0.76%
1/131 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/131 • 3 months
|
4.6%
5/108 • Number of events 5 • 3 months
|
0.00%
0/23 • 3 months
|
0.00%
0/131 • 3 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.5%
2/131 • Number of events 2 • 3 months
|
3.7%
4/108 • Number of events 4 • 3 months
|
4.3%
1/23 • Number of events 1 • 3 months
|
0.00%
0/131 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place