メトヴィクシアの皮膚浸透に対する機械的浸透促進剤の比較

アクティブコンパレータ：マイクロニードルの前処理とメトビクシア

マイクロニードルによる前処理とメトヴィクシアクリームの塗布を含むミニゾーン

デバイス：マイクロニードルの前処理

他の名前：

• ダーマローラー

薬：メトヴィクシアクリーム

他の名前：

• マル

アクティブコンパレータ：マイクロニードルの前処理と閉塞下のメトビクシア

マイクロニードルによる前処理と閉塞を伴うメトヴィクシア クリーム塗布を伴うミニゾーン

デバイス：マイクロニードルの前処理

他の名前：

• ダーマローラー

薬：メトヴィクシアクリーム

他の名前：

• マル

他の：密閉包帯

アクティブコンパレータ：レーザー前処理とメトビクシア

レーザー前処理とメトヴィシアクリーム塗布を含むミニゾーン

薬：メトヴィクシアクリーム

他の名前：

• マル

デバイス：アブレーションフラクショナル CO2 レーザーの前処理

アクティブコンパレータ：レーザー前処理と閉塞下のメトビクシア

レーザー前処理と閉塞を伴うメトヴィクシア クリーム塗布を伴うミニゾーン

薬：メトヴィクシアクリーム

他の名前：

• マル

他の：密閉包帯

デバイス：アブレーションフラクショナル CO2 レーザーの前処理

アクティブコンパレータ：メトヴィシア

メトビクシアクリームを塗布したミニゾーン（前処理なし）

薬：メトヴィクシアクリーム

他の名前：

• マル

アクティブコンパレータ：閉塞下のメトビクシア

前処理なしで、閉塞下でメトビクシアクリームを塗布したミニゾーン

薬：メトヴィクシアクリーム

他の名前：

• マル

他の：密閉包帯

実験的：マイクロニードルの前処理のみ

マイクロニードル前処理のみのミニゾーン

デバイス：マイクロニードルの前処理

他の名前：

• ダーマローラー

実験的：レーザー前処理のみ

レーザー前処理のみのミニゾーン

デバイス：アブレーションフラクショナル CO2 レーザーの前処理

介入なし：正常な皮膚

ノーマルスキンコントロールミニゾーン

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.

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.

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.

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.

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.

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.

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).