Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

NCT02511145 | Completed Phase 1 Results

• 2 other identifiers: RD.03.SPR.40221E2013-003371-35
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (5)

• 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 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)

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)

  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)

Study Arms (9)

Microneedles pretreatment and Metvixia

ACTIVE COMPARATOR

minizone with Microneedles pretreatment and Metvixia cream application

Device: Microneedles pretreatment; Drug: METVIXIA Cream

Microneedles pretreatment and Metvixia under occlusion

ACTIVE COMPARATOR

minizone with Microneedles pretreatment and Metvixia cream application with occlusion

Other: occlusive bandage; Device: Microneedles pretreatment; Drug: METVIXIA Cream

Laser pretreatment and Metvixia

ACTIVE COMPARATOR

minizone with laser pretreatment and Metvixia cream application

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

Other: occlusive bandage; Device: ablative fractional CO2 laser pretreatment; Drug: METVIXIA Cream

Metvixia

ACTIVE COMPARATOR

minizone with Metvixia cream application, without pretreatment

Drug: METVIXIA Cream

Metvixia under occlusion

ACTIVE COMPARATOR

minizone with Metvixia cream application under occlusion, without pretreatment

Other: occlusive bandage; Drug: METVIXIA Cream

Microneedles pretreatment only

EXPERIMENTAL

minizone with Microneedles pretreatment only

Device: Microneedles pretreatment

Laser pretreatment only

EXPERIMENTAL

minizone with Laser pretreatment only

Device: ablative fractional CO2 laser pretreatment

Normal skin

NO INTERVENTION

Normal skin control mini-zone

Interventions

occlusive bandage OTHER

Laser pretreatment and Metvixia under occlusion; Metvixia under occlusion; Microneedles pretreatment and Metvixia under occlusion

METVIXIA Cream DRUG

Also known as: MAL

Laser pretreatment and Metvixia; Laser pretreatment and Metvixia under occlusion; Metvixia; Metvixia under occlusion; Microneedles pretreatment and Metvixia; 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 pretreatment DEVICE

Also known as: Dermaroller

Microneedles pretreatment and Metvixia; Microneedles pretreatment and Metvixia under occlusion; Microneedles pretreatment only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

MeSH Terms

Interventions

Occlusive Dressings

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 29, 2015
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04