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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003371-35 | EudraCT Number |
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Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy volunteers to compare the effect on MAL penetration into the skin following various mechanical penetration enhancement techniques.
At baseline, each mini-zone was selected and randomly assigned to a pretreatment: 3 zones with microneedling Dermaroller®, 3 zones with ablative fractional CO2 Laser, and 3 zones with no pretreatment. After performing pretreatment, MAL cream was applied on the 6 assigned mini-zones for 3 hours incubation. Each condition was tested with and without occlusion. The three mini-zones with no product applied were used to perform biophysics measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedles pretreatment and Metvixia | Active Comparator | minizone with Microneedles pretreatment and Metvixia cream application |
|
| Microneedles pretreatment and Metvixia under occlusion | Active Comparator | minizone with Microneedles pretreatment and Metvixia cream application with occlusion |
|
| Laser pretreatment and Metvixia | Active Comparator | minizone with laser pretreatment and Metvixia cream application |
|
| Laser pretreatment and Metvixia under occlusion | Active Comparator | minizone with Laser pretreatment and Metvixia cream application with occlusion |
|
| Metvixia | Active Comparator | minizone with Metvixia cream application, without pretreatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| occlusive bandage | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application) | Spectrofluorometer probe in contact with skin was used to measure surface, deeper skin fluorescence, using different photoactive Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate quantity of PpIX in skin, corresponding with degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes,1 hour(hr),2hr, 3hr after Metvixia® application (immediately after cream removal at 3hr time point). Fluorescence data obtained using spectrofluorometer probe for two wavelengths that is, 405 nanometer(nm) measured fluorescence on skin surface, 632nm measured fluorescence in deep skin reported in this outcome measure. Maximal value was used to characterize Peak Effect, time point of this value was used to characterize Time to Peak. Negative values meant there was no longer fluorescence, it was corrected measurement derived from fluorescence. | At T0 (before Metvixia® application ) |
| Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T30 (30 Minutes After Metvixia® Application) | A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point). Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure. The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak. | At T0+ 30 minutes (30 minutes after Metvixia® application) |
| Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 1 Hour (After Metvixia® Application) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Fluorescence Levels Measured by Mini-zone Photo Camera Device at Timepoint T0 (Before Metvixia® Application) and 3 Hours (After Metvixia® Application and Immediately After Cream Removal) | A mini-zone camera device was used to measure skin surface fluorescence at a single excitation wavelength 405 nm before, and after Metvixia® application. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. This device uses the classical excitation wavelength: 405nm, was designed for Actinic Keratoses (AK) and had fluorescence references included. Pictures were performed for each zone before pre-treatment and after cream removal at visit 2 (V2) for documentation of fluorescence. |
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Inclusion Criteria:
Exclusion Criteria:
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Study drug was tested under 3 different conditions (2 pre-treatments-using Homecare Dermaroller and CO2 Ablative Fractional Laser, and normal skin) each of which was tested under occlusion and without occlusion for a total of 6 mini-zones applied. In addition, 3 mini-zones were pre-treated but no product was applied. In total, all these conditions was tested on 9 different mini zones (at back) of 2*2 centimeters (cm) area (4 cm^2) on each participant.
The study was conducted from 27 Feb 2014 to 09 May 2014.
| ID | Title | Description |
|---|---|---|
| FG000 | Non Treated Skin: Metvixia With Occlusion | All Participants with 9 designated mini-zones and who did not receive any pretreatment were topically administered 0.33 grams (g) Metvixia cream with occlusion at one mini-zone for three hours before the cream was removed. |
| FG001 | Non Treated Skin: Metvixia Without Occlusion | All Participants with 9 designated mini-zones and who did not receive any pretreatment were administered one mini-zone with 0.33 g Metvixia® cream without occlusion applied topically for three hours before the cream was removed were included in this arm. |
| FG002 | Dermaroller: Metvixia With Occlusion | All Participants with 9 designated mini-zones and who received homecare dermaroller pretreatment were administered one mini-zone with 0.33 g Metvixia® cream without occlusion applied topically for three hours before the cream was removed were included in this arm. |
| FG003 | Dermaroller: Metvixia Without Occlusion | All Participants with 9 designated mini-zones and who received homecare dermaroller pretreatment were administered one mini-zone with 0.33 g Metvixia® cream without occlusion applied topically for three hours before the cream was removed were included in this arm. |
| FG004 | Laser: Metvixia With Occlusion | All Participants with 9 designated mini-zones and who received CO2 Ablative Fractional Laser pretreatment were administered one mini-zone with 0.33 g Metvixia® cream with occlusion applied topically for three hours before the cream was removed were included in this arm. |
| FG005 | Laser: Metvixia Without Occlusion | All Participants with 9 designated mini-zones and who received CO2 Ablative Fractional Laser pretreatment were administered one mini-zone with 0.33 g Metvixia® cream without occlusion applied topically for three hours before the cream was removed were included in this arm. |
| FG006 | No Treatment Group | Participants 3 designated mini-zones were remain un-treated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
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| Period 1 |
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Intent-To-Treat population (ITT) consisted of randomized participants for whom at least one measurement was made on one zone.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants had 9 designated mini-zones of 4 centimeters square (cm^2) each on the back, of which 6 mini-zones were randomly allocated to receive pretreatment i.e., 3 were randomly pretreated skin with 0.33 grams (g) Metvixia cream using Homecare Dermaroller and 3 were randomly pretreated skin with 0.33 g Metvixia cream using a CO2 Ablative Fractional Laser whereas 3 mini-zones were not pretreated and were comparators for the pretreated mini-zones (untreated). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application) | Spectrofluorometer probe in contact with skin was used to measure surface, deeper skin fluorescence, using different photoactive Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate quantity of PpIX in skin, corresponding with degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes,1 hour(hr),2hr, 3hr after Metvixia® application (immediately after cream removal at 3hr time point). Fluorescence data obtained using spectrofluorometer probe for two wavelengths that is, 405 nanometer(nm) measured fluorescence on skin surface, 632nm measured fluorescence in deep skin reported in this outcome measure. Maximal value was used to characterize Peak Effect, time point of this value was used to characterize Time to Peak. Negative values meant there was no longer fluorescence, it was corrected measurement derived from fluorescence. | ITT population consisted of randomized participants for whom at least one measurement was made on one zone. Data were not collected for the three untreated mini-zones. | Posted | Mean | Standard Deviation | Nanometer (nm) | At T0 (before Metvixia® application ) | Skin Zones | Skin Zones |
From the start of study drug administration up to end of the study (up to 5 days)
Safety population consists of all randomized participants who received any amount of treatment in this study (pretreatment procedures or Metvixia® treatment). Adverse events were not collected for the three untreated mini-zones.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non Treated Skin: Metvixia With Occlusion | All Participants with 9 designated mini-zones and who did not receive any pretreatment were topically administered 0.33 g Metvixia cream with occlusion at one mini-zone for three hours before the cream was removed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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| ID | Term |
|---|---|
| D009779 | Occlusive Dressings |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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| Metvixia under occlusion | Active Comparator | minizone with Metvixia cream application under occlusion, without pretreatment |
|
| Microneedles pretreatment only | Experimental | minizone with Microneedles pretreatment only |
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| Laser pretreatment only | Experimental | minizone with Laser pretreatment only |
|
| Normal skin | No Intervention | Normal skin control mini-zone |
| ablative fractional CO2 laser pretreatment | Device |
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| Microneedles pretreatment | Device |
|
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| METVIXIA Cream | Drug |
|
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A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point). Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure. The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak. |
| At 1 Hour (After Metvixia® Application) |
| Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 2 Hour (After Metvixia® Application) | A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point). Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure. The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak. | At T0+ 2 Hour (After Metvixia® Application) |
| Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 3 Hour (After Metvixia® Application) | A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point). Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure. The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak. | At 3 Hour (After Metvixia® Application) |
| At T0 (Before Metvixia® application) and 3 Hours (After Metvixia® Application and Immediately After Cream Removal) |
| Fluorescence Levels Measured by Trans-Epidermal Water Loss (TEWL) at Timepoint T0 (Before Metvixia® Application) | TEWL evaluated the efficiency of the skin water barrier, which correlates with the degree of damage to the barrier function of the stratum corneum. TEWL was assessed on the mini-zones that were not treated with Metvixia®. It was measured in Grams of Water Per Square Meter Per Hour (g/m^2/hr). | At timepoint T0 (Before Metvixia® application) |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Skin phototype II | Fitzpatrick Skin Type is a numerical classification scale for the color of skin from Type I to Type VI. Type I= always burns, never tans, Type II= usually burns, tans minimally (light colored but darker than fair), Type III= sometimes mild burn, tans uniformly (golden honey or olive), Type IV= burns minimally, always tan well (moderate brown), Type V= very rarely burns, tans very easily (dark brown), Type VI= never burns (deeply pigmented dark brown to darkest brown). | Count of Participants | Participants |
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| Skin phototype III | Fitzpatrick Skin Type is a numerical classification scale for the color of skin from Type I to Type VI. Type I= always burns, never tans, Type II= usually burns, tans minimally (light colored but darker than fair), Type III= sometimes mild burn, tans uniformly (golden honey or olive), Type IV= burns minimally, always tan well (moderate brown), Type V= very rarely burns, tans very easily (dark brown), Type VI= never burns (deeply pigmented dark brown to darkest brown). | Count of Participants | Participants |
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| Primary | Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T30 (30 Minutes After Metvixia® Application) | A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point). Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure. The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak. | ITT population consists of randomized participants for whom at least one measurement was made on one zone. Data were not collected for the three untreated mini-zones. | Posted | Mean | Standard Deviation | Nanometer (nm) | At T0+ 30 minutes (30 minutes after Metvixia® application) | Skin Zones | Skin Zones |
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| Primary | Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 1 Hour (After Metvixia® Application) | A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point). Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure. The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak. | ITT population consisted of randomized participants for whom at least one measurement was made on one zone. Data were not collected for the three untreated mini-zones. | Posted | Mean | Standard Deviation | Nanometer (nm) | At 1 Hour (After Metvixia® Application) | Skin Zones | Skin Zones |
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| Primary | Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 2 Hour (After Metvixia® Application) | A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point). Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure. The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak. | ITT population consisted of randomized participants for whom at least one measurement was made on one zone. Data were not collected for the three untreated mini-zones. | Posted | Mean | Standard Deviation | Nanometer (nm) | At T0+ 2 Hour (After Metvixia® Application) | Skin Zones | Skin Zones |
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| Primary | Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 3 Hour (After Metvixia® Application) | A spectrofluorometer probe in contact with the skin was used to measure surface, as well as deeper skin fluorescence, using different Protoporphyrin IX (PpIX) excitation wavelengths. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. Three measurements were taken at different locations within each mini-zone at 5 time points: T0 (before Metvixia® application), and 30 minutes, 1 hour, 2 hours and 3 hours after Metvixia® application (immediately after cream removal at the 3 hour time point). Fluorescence data obtained using the spectrofluorometer probe for the two wavelengths that is, 405 nm measured fluorescence on skin surface and 632 nm measured fluorescence in deep skin were reported in this outcome measure. The maximal value was used to characterize the Peak Effect, and the time point of this value was used to characterize the Time to Peak. | ITT population consisted of randomized participants for whom at least one measurement was made on one zone. Data were not collected for the three untreated mini-zones. | Posted | Mean | Standard Deviation | Nanometer (nm) | At 3 Hour (After Metvixia® Application) | Skin Zones | Skin Zones |
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| Secondary | Mean Fluorescence Levels Measured by Mini-zone Photo Camera Device at Timepoint T0 (Before Metvixia® Application) and 3 Hours (After Metvixia® Application and Immediately After Cream Removal) | A mini-zone camera device was used to measure skin surface fluorescence at a single excitation wavelength 405 nm before, and after Metvixia® application. Fluorescence measurements were used to estimate the quantity of PpIX in the skin, corresponding with the degree of Metvixia® skin penetration. This device uses the classical excitation wavelength: 405nm, was designed for Actinic Keratoses (AK) and had fluorescence references included. Pictures were performed for each zone before pre-treatment and after cream removal at visit 2 (V2) for documentation of fluorescence. | ITT population consisted of randomized participants for whom at least one measurement was made on one zone. Here, "Overall Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here "Number analyzed" signifies those participants who were evaluable for this outcome measure at the specified time point. Data were not collected for the three untreated mini-zones. | Posted | Mean | Standard Deviation | Nanometer (nm) | At T0 (Before Metvixia® application) and 3 Hours (After Metvixia® Application and Immediately After Cream Removal) | Skin Zones | Skin Zones |
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| Secondary | Fluorescence Levels Measured by Trans-Epidermal Water Loss (TEWL) at Timepoint T0 (Before Metvixia® Application) | TEWL evaluated the efficiency of the skin water barrier, which correlates with the degree of damage to the barrier function of the stratum corneum. TEWL was assessed on the mini-zones that were not treated with Metvixia®. It was measured in Grams of Water Per Square Meter Per Hour (g/m^2/hr). | ITT population consisted of randomized participants for whom at least one measurement was made on one zone. Data were not collected for the three untreated mini-zones. | Posted | Mean | Standard Deviation | g/m^2/hr | At timepoint T0 (Before Metvixia® application) | Skin Zones | Skin Zones |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Non Treated Skin: Metvixia Without Occlusion | All Participants with 9 designated mini-zones and who did not receive any pretreatment were administered one mini-zone with 0.33 g Metvixia® cream without occlusion applied topically for three hours before the cream was removed were included in this arm. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Dermaroller: Metvixia With Occlusion | All Participants with 9 designated mini-zones and who received homecare dermaroller pretreatment were administered one mini-zone with 0.33 g Metvixia® cream with occlusion applied topically for three hours before the cream was removed were included in this arm. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG003 | Dermaroller: Metvixia Without Occlusion | All Participants with 9 designated mini-zones and who received homecare dermaroller pretreatment were administered one mini-zone with 0.33 g Metvixia® cream without occlusion applied topically for three hours before the cream was removed were included in this arm. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG004 | Laser: Metvixia With Occlusion | All Participants with 9 designated mini-zones and who received CO2 Ablative Fractional Laser pretreatment were administered one mini-zone with 0.33 g Metvixia® cream with occlusion applied topically for three hours before the cream was removed were included in this arm. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG005 | Laser: Metvixia Without Occlusion | All Participants with 9 designated mini-zones and who received CO2 Ablative Fractional Laser pretreatment were administered one mini-zone with 0.33 g Metvixia® cream without occlusion applied topically for three hours before the cream was removed were included in this arm. | 0 | 10 | 0 | 10 | 1 | 10 |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Skin Zones |
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| Fluorescence in deep skin (632 nm) |
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| Skin Zones |
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| Fluorescence in deep skin (632 nm) |
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| Skin Zones |
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| Fluorescence in deep skin (632 nm) |
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| Skin Zones |
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| Fluorescence in deep skin (632 nm) |
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| Skin Zones |
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| At 3 Hours (After Metvixia® Application and Immediately After Cream Removal) |
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