Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Device: Microneedles pretreatmentOther: occlusive bandageDevice: ablative fractional CO2 laser pretreatment
- Registration Number
- NCT02511145
- Lead Sponsor
- Galderma R&D
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Laser pretreatment and Metvixia METVIXIA Cream minizone with laser pretreatment and Metvixia cream application Metvixia under occlusion METVIXIA Cream minizone with Metvixia cream application under occlusion, without pretreatment Microneedles pretreatment and Metvixia Microneedles pretreatment minizone with Microneedles pretreatment and Metvixia cream application Laser pretreatment and Metvixia under occlusion ablative fractional CO2 laser pretreatment minizone with Laser pretreatment and Metvixia cream application with occlusion Metvixia METVIXIA Cream minizone with Metvixia cream application, without pretreatment Microneedles pretreatment only Microneedles pretreatment minizone with Microneedles pretreatment only Microneedles pretreatment and Metvixia under occlusion occlusive bandage minizone with Microneedles pretreatment and Metvixia cream application with occlusion Laser pretreatment and Metvixia ablative fractional CO2 laser pretreatment minizone with laser pretreatment and Metvixia cream application Microneedles pretreatment and Metvixia METVIXIA Cream minizone with Microneedles pretreatment and Metvixia cream application Microneedles pretreatment and Metvixia under occlusion Microneedles pretreatment minizone with Microneedles pretreatment and Metvixia cream application with occlusion Laser pretreatment only ablative fractional CO2 laser pretreatment minizone with Laser pretreatment only Microneedles pretreatment and Metvixia under occlusion METVIXIA Cream minizone with Microneedles pretreatment and Metvixia cream application with occlusion Laser pretreatment and Metvixia under occlusion occlusive bandage minizone with Laser pretreatment and Metvixia cream application with occlusion Laser pretreatment and Metvixia under occlusion METVIXIA Cream minizone with Laser pretreatment and Metvixia cream application with occlusion Metvixia under occlusion occlusive bandage minizone with Metvixia cream application under occlusion, without pretreatment
- Primary Outcome Measures
Name Time Method fluorescence of protoporphyrin IX (PpIX) 3 hours
- Secondary Outcome Measures
Name Time Method