Actinic Keratoses
Conditions
Brief summary
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).
Interventions
DRUGMetvix and natural daylight PDT
Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
DRUGMetvix and conventional PDT
Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female above 18 years; 2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);
Exclusion criteria
1. Subject with clinical diagnosis of at least one severe AK on TAs 2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs; 3. Subject with pigmented AK on the TAs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Response | Week12 | Percent of lesions treated at Baseline, in complete response at Week 12 |
| Pain Score | Baseline (during procedure), assessed after procedure | Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain) |
Countries
Australia
Participant flow
Recruitment details
100 subjects recruited from March 2012 to May 2012 in private practice and clinic.
Pre-assignment details
No significant events
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Enrolled Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | All Subjects Enrolled |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 59 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age, Continuous | 66.9 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment Australia | 100 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 100 | 59 / 100 |
| serious Total, serious adverse events | 9 / 100 | 9 / 100 |
Outcome results
Primary
Lesion Response
Percent of lesions treated at Baseline, in complete response at Week 12
Time frame: Week12
Population: Only Per Protocol subjects are included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metvix and Daylight | Lesion Response | 89.2 percentage of lesions complete response | Standard Deviation 15 |
| Metvix and Lamp | Lesion Response | 92.8 percentage of lesions complete response | Standard Deviation 14.1 |
Comparison: The primary purpose of this study is to demonstrate the non-inferiority of Metvix and daylight compared to Metvix and the lamp in terms of lesion complete response rate.p-value: 0.0345paired Student's t statistic
Primary
Pain Score
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
Time frame: Baseline (during procedure), assessed after procedure
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metvix and Daylight | Pain Score | 0.8 units on a scale | Standard Deviation 1.2 |
| Metvix and Lamp | Pain Score | 5.7 units on a scale | Standard Deviation 2.3 |
Comparison: superiority of Metvix adaylight and Metvix Lamp in term of painp-value: <0.001Wilcoxon (Mann-Whitney)