Trial Outcomes & Findings for Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp (NCT NCT00304239)
NCT ID: NCT00304239
Last Updated: 2023-07-03
Results Overview
Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
At Week 13
Results posted on
2023-07-03
Participant Flow
The study was conducted at 12 centers in Germany and the United States from 13 March 2006 to 23 January 2007.
A total of 131 participants were enrolled and received treatment in this study.
Participant milestones
| Measure |
Metvix-PDT
Participants received Metvix-PDT (methyl aminolevulinate hydrochloride-Photodynamic therapy) 160 milligrams per gram (mg/g) cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Vehicle-PDT
Participants received Vehicle cream (Vehicle-PDT) on face and/or scalp for 3 hours on Day 0 and Day 7.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
58
|
|
Overall Study
COMPLETED
|
56
|
58
|
|
Overall Study
NOT COMPLETED
|
17
|
0
|
Reasons for withdrawal
| Measure |
Metvix-PDT
Participants received Metvix-PDT (methyl aminolevulinate hydrochloride-Photodynamic therapy) 160 milligrams per gram (mg/g) cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Vehicle-PDT
Participants received Vehicle cream (Vehicle-PDT) on face and/or scalp for 3 hours on Day 0 and Day 7.
|
|---|---|---|
|
Overall Study
Protocol Deviations/Violations
|
15
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
Baseline characteristics by cohort
| Measure |
Metvix-PDT
n=73 Participants
Participants received Metvix-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Vehicle-PDT
n=58 Participants
Participants received Vehicle-PDT on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
73 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 13Population: Intention-to-treat (ITT) population consisted of all participants that were randomized and for whom any aspect of treatment with either Metvix-PDT or Vehicle-PDT was initiated.
Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator.
Outcome measures
| Measure |
Metvix-PDT
n=57 Participants
Participants received Metvix-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Vehicle-PDT
n=58 Participants
Participants received Vehicle-PDT on face and/or scalp for 3 hours on Day 0 and Day 7.
|
|---|---|---|
|
Participant Complete Response Rate (CRR)
|
68.4 Percentage of participants
Interval 54.8 to 80.1
|
6.9 Percentage of participants
Interval 1.9 to 16.7
|
SECONDARY outcome
Timeframe: At Week 13Population: Intention-to-treat (ITT) population consisted of all participants that were randomized and for whom any aspect of treatment with either Metvix-PDT or Vehicle-PDT was initiated.
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) after treatment. Percentage of lesions reported by location.
Outcome measures
| Measure |
Metvix-PDT
n=418 Lesion number
Participants received Metvix-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Vehicle-PDT
n=414 Lesion number
Participants received Vehicle-PDT on face and/or scalp for 3 hours on Day 0 and Day 7.
|
|---|---|---|
|
Lesion Complete Response Rate
Face
|
89 Percentage of lesions
|
28 Percentage of lesions
|
|
Lesion Complete Response Rate
Scalp
|
81 Percentage of lesions
|
30 Percentage of lesions
|
SECONDARY outcome
Timeframe: From start of study drug administration up to Week 13Population: The safety population consisted of all participants for whom any kind of treatment was initiated.
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with at least one treatment site adverse events were reported.
Outcome measures
| Measure |
Metvix-PDT
n=73 Participants
Participants received Metvix-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Vehicle-PDT
n=58 Participants
Participants received Vehicle-PDT on face and/or scalp for 3 hours on Day 0 and Day 7.
|
|---|---|---|
|
Number of Participants With at Least One Treatment Site Adverse Events
|
61 Participants
|
27 Participants
|
Adverse Events
Metvix-PDT
Serious events: 6 serious events
Other events: 62 other events
Deaths: 0 deaths
Vehicle-PDT
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metvix-PDT
n=73 participants at risk
Participants received Metvix-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Vehicle-PDT
n=58 participants at risk
Participant received Vehicle-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Cerebral Concussion
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Investigations
Hospitalization for coronary cateterization
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Surgical and medical procedures
Basal cell carcinoma nose surgery
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Surgical and medical procedures
Surgery of squamous cell carcinoma right cheek
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Surgical and medical procedures
Re-surgery of squamous cell carcinoma right cheek
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Surgical and medical procedures
Lentigo maligna surgery
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Surgical and medical procedures
Planned three-step surgery of preexisting squamous cell carcinoma
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Surgical and medical procedures
Basal cell carcinoma left cheek surgery
|
0.00%
0/73 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
1.7%
1/58 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Surgical and medical procedures
Re-surgery and wound suture basal cell carcinoma left cheek
|
0.00%
0/73 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
1.7%
1/58 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Surgical and medical procedures
Knee prothesis right due to arthrosis participants affected / exposed
|
0.00%
0/73 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
1.7%
1/58 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Nervous system disorders
Retrograde amnesia and anterograde amnesia due to cerebral concussion
|
1.4%
1/73 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
0.00%
0/58 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/73 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
1.7%
1/58 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
Other adverse events
| Measure |
Metvix-PDT
n=73 participants at risk
Participants received Metvix-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
Vehicle-PDT
n=58 participants at risk
Participant received Vehicle-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
54.8%
40/73 • Number of events 40 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
20.7%
12/58 • Number of events 12 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
52.1%
38/73 • Number of events 38 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
5.2%
3/58 • Number of events 3 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
35.6%
26/73 • Number of events 26 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
20.7%
12/58 • Number of events 12 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.5%
15/73 • Number of events 15 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
3.4%
2/58 • Number of events 2 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
13.7%
10/73 • Number of events 10 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
5.2%
3/58 • Number of events 3 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
15.1%
11/73 • Number of events 11 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
1.7%
1/58 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
|
Skin and subcutaneous tissue disorders
Scab
|
15.1%
11/73 • Number of events 11 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
1.7%
1/58 • Number of events 1 • From study drug administration up to Week 13
The safety population consisted of all participants for whom any kind of treatment was initiated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place