HealthyPhase 1NCT02511145

Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

A Phase 1 study testing occlusive bandage, ablative fractional CO2 laser pretreatment and Microneedles pretreatment in people with Healthy, run by Galderma R&D.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: occlusive bandage, ablative fractional CO2 laser pretreatment and Microneedles pretreatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Feb 2014to May 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

About this study

Official title: Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration

Read the detailed description

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.

Conditions: Healthy
Being tested: occlusive bandage, ablative fractional CO2 laser pretreatment, Microneedles pretreatment, METVIXIA Cream
Keywords: volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

occlusive bandageOther
ablative fractional CO2 laser pretreatmentDevice
Microneedles pretreatmentDevice
Also called Dermaroller
METVIXIA CreamDrug
Also called MAL

Study groups in NCT02511145
Study group	Role	What they receive
Microneedles pretreatment and Metvixia	Active comparator	minizone with Microneedles pretreatment and Metvixia cream application Receives: Device: Microneedles pretreatment; Drug: METVIXIA Cream
Microneedles pretreatment and Metvixia under occlusion	Active comparator	minizone with Microneedles pretreatment and Metvixia cream application with occlusion Receives: Other: occlusive bandage; Device: Microneedles pretreatment; Drug: METVIXIA Cream
Laser pretreatment and Metvixia	Active comparator	minizone with laser pretreatment and Metvixia cream application Receives: Device: ablative fractional CO2 laser pretreatment; Drug: METVIXIA Cream
Laser pretreatment and Metvixia under occlusion	Active comparator	minizone with Laser pretreatment and Metvixia cream application with occlusion Receives: Other: occlusive bandage; Device: ablative fractional CO2 laser pretreatment; Drug: METVIXIA Cream
Metvixia	Active comparator	minizone with Metvixia cream application, without pretreatment Receives: Drug: METVIXIA Cream
Metvixia under occlusion	Active comparator	minizone with Metvixia cream application under occlusion, without pretreatment Receives: Other: occlusive bandage; Drug: METVIXIA Cream
Microneedles pretreatment only	Experimental	minizone with Microneedles pretreatment only Receives: Device: Microneedles pretreatment
Laser pretreatment only	Experimental	minizone with Laser pretreatment only Receives: Device: ablative fractional CO2 laser pretreatment
Normal skin	No intervention	Normal skin control mini-zone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: At T0+ 30 minutes (30 minutes after Metvixia® application)
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.
Measured: 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.
Measured: 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.
Measured: At 3 Hour (After Metvixia® Application)

Secondary outcomes (2)

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.
Measured: 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).
Measured: At timepoint T0 (Before Metvixia® application)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014May 2014

First posted29 Jul 2015 (estimated)
Study startFeb 2014
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02511145
Sponsor's protocol ID: RD.03.SPR.40221E
Other IDs: 2013-003371-35
Status last verified: Apr 2026
First submitted: 28 Jul 2015
Last updated: 1 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration
ClinicalTrials.gov ID: NCT02511145
Acronym / sponsor ID: RD.03.SPR.40221E
Conditions: Healthy
Keywords: volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Feb 2014 (actual)
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 29 Jul 2015 (estimated)
Results: Posted 1 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Microneedles pretreatment and Metvixia	Active comparator	Device: Microneedles pretreatment, Drug: METVIXIA Creamminizone with Microneedles pretreatment and Metvixia cream application
Microneedles pretreatment and Metvixia under occlusion	Active comparator	Other: occlusive bandage, Device: Microneedles pretreatment, Drug: METVIXIA Creamminizone with Microneedles pretreatment and Metvixia cream application with occlusion
Laser pretreatment and Metvixia	Active comparator	Device: ablative fractional CO2 laser pretreatment, Drug: METVIXIA Creamminizone with laser pretreatment and Metvixia cream application
Laser pretreatment and Metvixia under occlusion	Active comparator	Other: occlusive bandage, Device: ablative fractional CO2 laser pretreatment, Drug: METVIXIA Creamminizone with Laser pretreatment and Metvixia cream application with occlusion
Metvixia	Active comparator	Drug: METVIXIA Creamminizone with Metvixia cream application, without pretreatment
Metvixia under occlusion	Active comparator	Other: occlusive bandage, Drug: METVIXIA Creamminizone with Metvixia cream application under occlusion, without pretreatment
Microneedles pretreatment only	Experimental	Device: Microneedles pretreatmentminizone with Microneedles pretreatment only
Laser pretreatment only	Experimental	Device: ablative fractional CO2 laser pretreatmentminizone with Laser pretreatment only
Normal skin	No intervention	–Normal skin control mini-zone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
occlusive bandage	Other	Laser pretreatment and Metvixia under occlusion, Metvixia under occlusion, Microneedles pretreatment and Metvixia under occlusion
ablative fractional CO2 laser pretreatment	Device	Laser pretreatment and Metvixia, Laser pretreatment and Metvixia under occlusion, Laser pretreatment only
Microneedles pretreatmentAlso: Dermaroller	Device	Microneedles pretreatment and Metvixia, Microneedles pretreatment and Metvixia under occlusion, Microneedles pretreatment only
METVIXIA CreamAlso: MAL	Drug	Laser pretreatment and Metvixia, Laser pretreatment and Metvixia under occlusion, Metvixia, Metvixia under occlusion, Microneedles pretreatment and Metvixia, Microneedles pretreatment and Metvixia under occlusion

Primary outcome

Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.

2 secondary outcomes

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)
Time frame: 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)
Time frame: At timepoint T0 (Before Metvixia® application)

Results and safety

Results posted to the registry on 1 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non Treated Skin: Metvixia With Occlusion	10	10
Non Treated Skin: Metvixia Without Occlusion	0	0
Dermaroller: Metvixia With Occlusion	0	0
Dermaroller: Metvixia Without Occlusion	0	0
Laser: Metvixia With Occlusion	0	0
Laser: Metvixia Without Occlusion	0	0
No Treatment Group	0	0

Primary outcome: Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application)

Time frame: At T0 (before Metvixia® application ). Mean (Standard Deviation). Unit: Nanometer (nm)

Measure	Non Treated Skin: Metvixia With Occlusion n = 10	Non Treated Skin: Metvixia Without Occlusion n = 10	Dermaroller: Metvixia With Occlusion n = 10	Dermaroller: Metvixia Without Occlusion n = 10	Laser: Metvixia With Occlusion n = 10	Laser: Metvixia Without Occlusion n = 10
Fluorescence on skin surface (405 nm)	6.41 (0.29)	6.37 (0.26)	6.51 (0.39)	6.38 (0.25)	6.35 (0.36)	6.44 (0.21)
Fluorescence in deep skin (632 nm)	-5.94 (0.64)	-6.22 (0.79)	-6.04 (0.82)	-6.32 (0.72)	-5.38 (1.91)	-6.01 (0.54)

Population analysed: 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.

Primary outcome: Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T30 (30 Minutes After Metvixia® Application)

Time frame: At T0+ 30 minutes (30 minutes after Metvixia® application). Mean (Standard Deviation). Unit: Nanometer (nm)

Measure	Non Treated Skin: Metvixia With Occlusion n = 10	Non Treated Skin: Metvixia Without Occlusion n = 10	Dermaroller: Metvixia With Occlusion n = 10	Dermaroller: Metvixia Without Occlusion n = 10	Laser: Metvixia With Occlusion n = 10	Laser: Metvixia Without Occlusion n = 10
Fluorescence on skin surface (405 nm)	6.88 (0.39)	7.32 (0.36)	7.20 (0.23)	7.33 (0.32)	6.90 (0.18)	7.29 (0.33)
Fluorescence in deep skin (632 nm)	-5.73 (0.84)	-5.68 (0.75)	-4.47 (0.54)	-4.71 (0.41)	-4.42 (0.57)	-4.48 (0.45)

Population analysed: 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.

Primary outcome: Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 1 Hour (After Metvixia® Application)

Time frame: At 1 Hour (After Metvixia® Application). Mean (Standard Deviation). Unit: Nanometer (nm)

Measure	Non Treated Skin: Metvixia With Occlusion n = 10	Non Treated Skin: Metvixia Without Occlusion n = 10	Dermaroller: Metvixia With Occlusion n = 10	Dermaroller: Metvixia Without Occlusion n = 10	Laser: Metvixia With Occlusion n = 10	Laser: Metvixia Without Occlusion n = 10
Fluorescence on skin surface (405 nm)	6.93 (0.35)	7.11 (0.44)	7.45 (0.25)	7.53 (0.38)	7.38 (0.29)	7.58 (0.22)
Fluorescence in deep skin (632 nm)	-5.15 (0.57)	-5.30 (0.96)	-3.64 (0.36)	-3.85 (0.53)	-3.35 (0.52)	-3.64 (0.34)

Population analysed: 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.

Primary outcome: Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 2 Hour (After Metvixia® Application)

Time frame: At T0+ 2 Hour (After Metvixia® Application). Mean (Standard Deviation). Unit: Nanometer (nm)

Measure	Non Treated Skin: Metvixia With Occlusion n = 10	Non Treated Skin: Metvixia Without Occlusion n = 10	Dermaroller: Metvixia With Occlusion n = 10	Dermaroller: Metvixia Without Occlusion n = 10	Laser: Metvixia With Occlusion n = 10	Laser: Metvixia Without Occlusion n = 10
Fluorescence on skin surface (405 nm)	7.14 (0.56)	7.33 (0.46)	8.10 (0.21)	7.98 (0.30)	8.14 (0.42)	8.16 (0.30)
Fluorescence in deep skin (632 nm)	-4.24 (0.97)	-4.56 (0.90)	-2.40 (0.37)	-2.63 (0.36)	-2.16 (0.79)	-2.18 (0.66)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of study drug administration up to end of the study (up to 5 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non Treated Skin: Metvixia With Occlusion	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Non Treated Skin: Metvixia Without Occlusion	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Dermaroller: Metvixia With Occlusion	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Dermaroller: Metvixia Without Occlusion	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Laser: Metvixia With Occlusion	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Laser: Metvixia Without Occlusion	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing occlusive bandage, ablative fractional CO2 laser pretreatment and Microneedles pretreatment in people with Healthy, run by Galderma R&D.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application) (time frame: At T0 (before Metvixia® application )). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02511145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.