Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

Galderma

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02511145

RD.03.SPR.40221E

2013-003371-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10 participants in 9 patient groups

Microneedles pretreatment and Metvixia

Active Comparator group

Description:

minizone with Microneedles pretreatment and Metvixia cream application

Treatment:

Drug: METVIXIA Cream

Device: Microneedles pretreatment

Microneedles pretreatment and Metvixia under occlusion

Active Comparator group

Description:

minizone with Microneedles pretreatment and Metvixia cream application with occlusion

Treatment:

Drug: METVIXIA Cream

Other: occlusive bandage

Device: Microneedles pretreatment

Laser pretreatment and Metvixia

Active Comparator group

Description:

minizone with laser pretreatment and Metvixia cream application

Treatment:

Drug: METVIXIA Cream

Device: ablative fractional CO2 laser pretreatment

Laser pretreatment and Metvixia under occlusion

Active Comparator group

Description:

minizone with Laser pretreatment and Metvixia cream application with occlusion

Treatment:

Drug: METVIXIA Cream

Other: occlusive bandage

Device: ablative fractional CO2 laser pretreatment

Metvixia

Active Comparator group

Description:

minizone with Metvixia cream application, without pretreatment

Treatment:

Drug: METVIXIA Cream

Metvixia under occlusion

Active Comparator group

Description:

minizone with Metvixia cream application under occlusion, without pretreatment

Treatment:

Drug: METVIXIA Cream

Other: occlusive bandage

Microneedles pretreatment only

Experimental group

Description:

minizone with Microneedles pretreatment only

Treatment:

Device: Microneedles pretreatment

Laser pretreatment only

Experimental group

Description:

minizone with Laser pretreatment only

Treatment:

Device: ablative fractional CO2 laser pretreatment

Normal skin

No Intervention group

Description:

Normal skin control mini-zone