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 in subjects with mild actinic keratoses (intra-individual comparison)
Interventions
DRUGMetvix®
PROCEDUREPhotodynamic Therapy Blue light
Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
PROCEDUREPhotodynamic Therapy Daylight
Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug
Sponsors
Galderma R&D
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female above 18 years; * Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);
Exclusion criteria
* Subject with clinical diagnosis of at least one severe AK on TAs * Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs; * Subject with pigmented AK on the TAs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 | Baseline and Week 12 | The number of lesions is assessed at baseline (before treatment) and 12 weeks later. The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assesment | at inclusion (after treatment) | Pain assesment with a VAS Pain scale Visual analog scale \[VAS\] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). |
| Lesions Disappearance Rate at 1 Months From Baseline. | 0(baseline),1 month | The number of lesions is assessed at baseline (before treatment) and 1 month later. The difference in lesions is recorded for each patient. The rate is the quotient: difference in lesions between baseline and at 1 month /nubmer of lesions at baseline |
| Lesions Disappearance Rate at 6 Months From Baseline. | 0(baseline), 6 month | The number of lesions is assessed at baseline (before treatment) and 6 month later. The difference in lesions is recorded for each patient. The rate is the quotient: difference in lesions between baseline and at 6 month /nubmer of lesions at baseline |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daylight Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
Metvix®
Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug | 13 |
| Conventional Treatment Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
Metvix®
Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Daylight | Conventional Treatment | Total |
|---|---|---|---|
| Age, Continuous | 75.0 year | 75.0 year | 75.0 year |
| Region of Enrollment France | 13 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 1 / 13 | 1 / 13 |
Outcome results
Primary
Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
The number of lesions is assessed at baseline (before treatment) and 12 weeks later. The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients.
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daylight | Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 | 19.6 number of lesions | Standard Deviation 6 |
| Conventional Treatment | Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 | 20.0 number of lesions | Standard Deviation 6.9 |
Comparison: Main analysis:~* nbDPKAdispM3 the number of KA disappeared at M3 after treatment with DPDT compared to the inclusion layer,~* nbCPKAdispM3 the number of KA disappeared at M3 after treatment with conventional blue light,~The primary endpoint is:~differenceM3 = nbDPKAdispM3 - nbCPKAdispM3 The main analysis will consist of a signed Wilcoxon rank test for matched data testing whether difference M3 is significantly different from 0p-value: 0.846Wilcoxon (Mann-Whitney)
Secondary
Lesions Disappearance Rate at 1 Months From Baseline.
The number of lesions is assessed at baseline (before treatment) and 1 month later. The difference in lesions is recorded for each patient. The rate is the quotient: difference in lesions between baseline and at 1 month /nubmer of lesions at baseline
Time frame: 0(baseline),1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daylight | Lesions Disappearance Rate at 1 Months From Baseline. | 89.6 percentage of disappeared lesions | Standard Deviation 7.2 |
| Conventional Treatment | Lesions Disappearance Rate at 1 Months From Baseline. | 94.6 percentage of disappeared lesions | Standard Deviation 4.8 |
p-value: 0.0005Wilcoxon (Mann-Whitney)
Secondary
Lesions Disappearance Rate at 6 Months From Baseline.
The number of lesions is assessed at baseline (before treatment) and 6 month later. The difference in lesions is recorded for each patient. The rate is the quotient: difference in lesions between baseline and at 6 month /nubmer of lesions at baseline
Time frame: 0(baseline), 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daylight | Lesions Disappearance Rate at 6 Months From Baseline. | 90.9 percentage of disappeared lesions | Standard Deviation 5.9 |
| Conventional Treatment | Lesions Disappearance Rate at 6 Months From Baseline. | 94.7 percentage of disappeared lesions | Standard Deviation 5.4 |
p-value: 0.0001Wilcoxon (Mann-Whitney)
Secondary
Pain Assesment
Pain assesment with a VAS Pain scale Visual analog scale \[VAS\] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10).
Time frame: at inclusion (after treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daylight | Pain Assesment | 1.2 units on a scale | Standard Deviation 1.9 |
| Conventional Treatment | Pain Assesment | 5.1 units on a scale | Standard Deviation 2.1 |