Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

April 10, 2026 updated by: Galderma R&D

Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Microneedles pretreatment and Metvixia
minizone with Microneedles pretreatment and Metvixia cream application
Device: Microneedles pretreatment
Other Names:
  • Dermaroller
Drug: METVIXIA Cream
Other Names:
  • MAL
Active Comparator: Microneedles pretreatment and Metvixia under occlusion
minizone with Microneedles pretreatment and Metvixia cream application with occlusion
Device: Microneedles pretreatment
Other Names:
  • Dermaroller
Drug: METVIXIA Cream
Other Names:
  • MAL
Other: occlusive bandage
Active Comparator: Laser pretreatment and Metvixia
minizone with laser pretreatment and Metvixia cream application
Drug: METVIXIA Cream
Other Names:
  • MAL
Device: ablative fractional CO2 laser pretreatment
Active Comparator: Laser pretreatment and Metvixia under occlusion
minizone with Laser pretreatment and Metvixia cream application with occlusion
Drug: METVIXIA Cream
Other Names:
  • MAL
Other: occlusive bandage
Device: ablative fractional CO2 laser pretreatment
Active Comparator: Metvixia
minizone with Metvixia cream application, without pretreatment
Drug: METVIXIA Cream
Other Names:
  • MAL
Active Comparator: Metvixia under occlusion
minizone with Metvixia cream application under occlusion, without pretreatment
Drug: METVIXIA Cream
Other Names:
  • MAL
Other: occlusive bandage
Experimental: Microneedles pretreatment only
minizone with Microneedles pretreatment only
Device: Microneedles pretreatment
Other Names:
  • Dermaroller
Experimental: Laser pretreatment only
minizone with Laser pretreatment only
Device: ablative fractional CO2 laser pretreatment
No Intervention: Normal skin
Normal skin control mini-zone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At T0 (before Metvixia® application )
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.
At T0+ 30 minutes (30 minutes after Metvixia® application)
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.
At 1 Hour (After Metvixia® Application)
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.
At T0+ 2 Hour (After Metvixia® Application)
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.
At 3 Hour (After Metvixia® Application)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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)
Time Frame: At 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.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RD.03.SPR.40221E
  • 2013-003371-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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