NCT02511145|CompletedPhase 1Results
Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration
Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
10
0 countries
N/A
Study Start
February 2014
Actual (reported)Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Actual (reported)May 2014
Actual (reported)May 2014
Actual (reported)July 28, 2015
Actual (reported)July 29, 2015
Actual (reported)May 1, 2026
Actual (reported)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 Mini-zone Photo Camera Device at Timepoint T0 (Before Metvixia® Application) and 3 Hours (After Metvixia® Application and Immediately After Cream Removal)
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)
At timepoint T0 (Before Metvixia® application)
minizone with Microneedles pretreatment and Metvixia cream application
minizone with Microneedles pretreatment and Metvixia cream application with occlusion
10 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2015
First Posted
July 29, 2015
Study Start
February 2014
Actual (reported)Primary Completion
Thorough QT Study of Intravenous Amisulpride
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.
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)
minizone with laser pretreatment and Metvixia cream application
minizone with Laser pretreatment and Metvixia cream application with occlusion
minizone with Metvixia cream application, without pretreatment
minizone with Metvixia cream application under occlusion, without pretreatment
minizone with Microneedles pretreatment only
minizone with Laser pretreatment only
Normal skin control mini-zone
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
May 1, 2026
Results First Posted
May 1, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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