Phase 1
N=10
Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02511145 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application) — 6.41; 6.37; 6.51; 6.38 Nanometer (nm)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- occlusive bandage (Other); ablative fractional CO2 laser pretreatment (Device); Microneedles pretreatment (Device); METVIXIA Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T0 (Before Metvixia® Application) |
6.41; 6.37; 6.51; 6.38; 6.35; 6.44 | — |
| PRIMARY Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint T30 (30 Minutes After Metvixia® Application) |
6.88; 7.32; 7.20; 7.33; 6.90; 7.29 | — |
| PRIMARY Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 1 Hour (After Metvixia® Application) |
6.93; 7.11; 7.45; 7.53; 7.38; 7.58 | — |
| PRIMARY Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 2 Hour (After Metvixia® Application) |
7.14; 7.33; 8.10; 7.98; 8.14; 8.16 | — |
| PRIMARY Mean Fluorescence Levels Measured by Spectrofluorometer Probe at Timepoint 3 Hour (After Metvixia® Application) |
7.36; 7.14; 8.59; 8.36; 8.63; 8.51 | — |
| SECONDARY 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) |
4.97; 5.09; 4.95; 5.10; 4.91; 5.04 | — |
| SECONDARY Fluorescence Levels Measured by Trans-Epidermal Water Loss (TEWL) at Timepoint T0 (Before Metvixia® Application) |
2.75; 3.63; 5.41 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02511145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.