Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 10
- 主要终点
- fluorescence of protoporphyrin IX (PpIX)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of non childbearing potential, who is at least 18 years of age or older at screening visit.
- •The subject has a skin phototype of I to III on Fitzpatrick's scale (Fitzpatrick et al., 1993) at screening visit.
- •Subject should have 9 mini zone areas on the back that will be able to receive pre-treatments according to protocol. (checked at Screening visit, and assigned at Baseline visit)
- •Female of non childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening visit, without any other medical reason], hysterectomy or bilateral oophorectomy).
排除标准
- •Subject with porphyria,
- •Subject with past history of skin cancer, or current clinical diagnosis of other skin disease (including non-melanoma skin cancer), or tattoos, or cheloid and hypertrophic scars on the test zones, which, in the opinion of the investigator, might interfere with the interpretation of the clinical results,
- •Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
- •Known or suspected allergies or sensitivities to any components of any of the study drugs (see Product label).
- •The subject has received, applied or taken some specific treatments within specified time frame prior to the baseline visit
研究组 & 干预措施
Normal skin
Normal skin control mini-zone
Microneedles pretreatment and Metvixia
minizone with Microneedles pretreatment and Metvixia cream application
干预措施: Microneedles pretreatment (Device)
Laser pretreatment and Metvixia under occlusion
minizone with Laser pretreatment and Metvixia cream application with occlusion
干预措施: ablative fractional CO2 laser pretreatment (Device)
Metvixia
minizone with Metvixia cream application, without pretreatment
干预措施: METVIXIA Cream (Drug)
Microneedles pretreatment only
minizone with Microneedles pretreatment only
干预措施: Microneedles pretreatment (Device)
Microneedles pretreatment and Metvixia under occlusion
minizone with Microneedles pretreatment and Metvixia cream application with occlusion
干预措施: occlusive bandage (Other)
Laser pretreatment and Metvixia
minizone with laser pretreatment and Metvixia cream application
干预措施: ablative fractional CO2 laser pretreatment (Device)
Laser pretreatment and Metvixia
minizone with laser pretreatment and Metvixia cream application
干预措施: METVIXIA Cream (Drug)
Microneedles pretreatment and Metvixia
minizone with Microneedles pretreatment and Metvixia cream application
干预措施: METVIXIA Cream (Drug)
Microneedles pretreatment and Metvixia under occlusion
minizone with Microneedles pretreatment and Metvixia cream application with occlusion
干预措施: Microneedles pretreatment (Device)
Laser pretreatment only
minizone with Laser pretreatment only
干预措施: ablative fractional CO2 laser pretreatment (Device)
Microneedles pretreatment and Metvixia under occlusion
minizone with Microneedles pretreatment and Metvixia cream application with occlusion
干预措施: METVIXIA Cream (Drug)
Laser pretreatment and Metvixia under occlusion
minizone with Laser pretreatment and Metvixia cream application with occlusion
干预措施: occlusive bandage (Other)
Laser pretreatment and Metvixia under occlusion
minizone with Laser pretreatment and Metvixia cream application with occlusion
干预措施: METVIXIA Cream (Drug)
Metvixia under occlusion
minizone with Metvixia cream application under occlusion, without pretreatment
干预措施: occlusive bandage (Other)
Metvixia under occlusion
minizone with Metvixia cream application under occlusion, without pretreatment
干预措施: METVIXIA Cream (Drug)
结局指标
主要结局
fluorescence of protoporphyrin IX (PpIX)
时间窗: 3 hours
Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application)
时间窗: At 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)
时间窗: At T0+ 30 minutes (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)
时间窗: At 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)
时间窗: At T0+ 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)
时间窗: At 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.
次要结局
- 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))